<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02255305</url>
  </required_header>
  <id_info>
    <org_study_id>EH 14-331</org_study_id>
    <nct_id>NCT02255305</nct_id>
  </id_info>
  <brief_title>FMT Versus Antimicrobials for Initial Treatment of Recurrent CDI</brief_title>
  <official_title>Fecal Microbiota Transplantation Versus Standard Medical Therapy for Initial Treatment of Recurrent Clostridium Difficile Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NorthShore University HealthSystem</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NorthShore University HealthSystem</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine the safety and efficacy of Fecal Microbiota&#xD;
      Transplant (FMT) for the treatment of the recurrence of Clostridium difficile infection (CDI)&#xD;
      as compared to standard antibiotic therapy. Patients who have tested positive for CDI within&#xD;
      90 days of an admission for relapse of CDI will be approached to participate in this&#xD;
      open-label, randomized controlled trial. Patients will either be randomized to the&#xD;
      intervention group (receive FMT via retention enema) or the control group (receive&#xD;
      antimicrobials targeting CDI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial is an open-label, randomized, controlled trial evaluating the safety and efficacy&#xD;
      of fecal microbiota transplantation (FMT) for the treatment of the recurrence of Clostridium&#xD;
      difficile infection (CDI) as compared to standard antibiotic therapy. Clostridium difficile&#xD;
      infection (CDI) has increased in incidence and severity over the last decade and is&#xD;
      associated with poor outcomes including increased morbidity, mortality, and healthcare costs&#xD;
      (1-8). Relapse occurs in 15-35% of patients after the first episode of CDI and 45-65% of&#xD;
      patients who have one relapse will experience a subsequent relapse (9, 10). Dysbiosis -&#xD;
      decreased diversity of the fecal microbiome - is thought to contribute to the high rate of&#xD;
      relapse (11). FMT quickly and successfully restores normal intestinal microorganisms of the&#xD;
      diseased patient via infusion of a liquid stool preparation from a healthy donor. FMT&#xD;
      resulted in disease resolution in ~90% of cases reported in a systematic review and&#xD;
      meta-analyses without any significant adverse events noted (12, 13).&#xD;
&#xD;
      All hospitalized patients in the NorthShore system &gt;18 years of age who are diagnosed with&#xD;
      active CDI, defined as &gt;3 diarrheal stools per day and a positive C. difficile polymerase&#xD;
      chain reaction (PCR) assay, will be evaluated for inclusion in the study. Hospitalized&#xD;
      patients presenting with their first or greater relapse of CDI occurring between 15 and 90&#xD;
      days after an index episode of CDI will be eligible for enrollment. Exclusion criteria will&#xD;
      include pregnancy, neutropenia (absolute neutrophil count &lt;1000/μl), contraindication for&#xD;
      retention enema, or food allergy not controlled for in the donor diet. Eligible patients will&#xD;
      undergo written informed consent followed by randomization into intervention and control&#xD;
      groups.&#xD;
&#xD;
      Patients who are randomized to the intervention group will have antimicrobials targeting C.&#xD;
      difficile discontinued at least 6 hours prior to undergoing an FMT via retention enema. A&#xD;
      second FMT via retention enema will be administered at 24 hours if diarrhea persists.&#xD;
      Patients randomized to the control group will be treated with antimicrobials targeting C.&#xD;
      difficile according to the Society for Healthcare Epidemiology of America Clinical Practice&#xD;
      Guidelines for CDI (18). FMT will be offered to the control group after 90 days if they&#xD;
      experience relapsing CDI.&#xD;
&#xD;
      Two healthy &quot;universal&quot; donors who have previously donated fecal material for FMT have&#xD;
      expressed willingness to participate in the study. Donors will complete the American&#xD;
      Association of Blood Banks donor questionnaire for exposure to infectious agents as well as&#xD;
      undergo serologic and stool testing for communicable diseases or pathogenic bacteria/viruses&#xD;
      as previously described (17).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to personnel issues for finding and enrolling patients, performing appropriate follow-up&#xD;
    and performing FMT procedure&#xD;
  </why_stopped>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">January 2020</completion_date>
  <primary_completion_date type="Actual">January 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Patients With Clinical Resolution of Diarrhea</measure>
    <time_frame>90 days</time_frame>
    <description>Number of patients with resolution of diarrhea and other abdominal symptoms or return to baseline symptoms that were present prior to C. difficile diagnosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Clinical Resolution of Symptoms</measure>
    <time_frame>90 days</time_frame>
    <description>Amount of time it takes for patient to have cessation of diarrhea and abdominal pain/gastrointestinal symptoms (or return to baseline) and normalization of white blood cell count, creatinine, and temperature.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Length of Stay</measure>
    <time_frame>90 days</time_frame>
    <description>Patients' length of stay post-procedure will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Hospital Readmission</measure>
    <time_frame>90 days</time_frame>
    <description>Number of patients re-admitted to the hospital for recurrent Clostridium difficile infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>90 days</time_frame>
    <description>Number of patients who died from any cause within 90 days of randomization</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Clostridium Difficile Infection</condition>
  <arm_group>
    <arm_group_label>FMT Group (Intervention Arm)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to the FMT group will have antimicrobials targeting C. difficile discontinued at least 6 hours prior to undergoing an FMT via retention enema. A second FMT via retention enema will be administered at 24 hours if diarrhea persists.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Antimicrobial Group (Control Arm)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to the antimicrobial group will be treated with antibiotics targeting C. difficile according to the Society for Healthcare Epidemiology of America (SHEA) Clinical Practice Guidelines for CDI. FMT will be offered to this group after 90 days if they experience relapsing CDI.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>FMT</intervention_name>
    <description>Patients in the FMT group will receive ~50 grams of fecal material suspended in bacteriostatic normal saline and glycerol.</description>
    <arm_group_label>FMT Group (Intervention Arm)</arm_group_label>
    <other_name>Fecal Microbiota Transplant</other_name>
    <other_name>Stool Transplant</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Antimicrobials</intervention_name>
    <description>Patients randomized to the control group will receive antimicrobials targeting C. difficile.</description>
    <arm_group_label>Antimicrobial Group (Control Arm)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of active C. difficile infection, defined as &gt; 3 diarrheal stools per day&#xD;
             and a positive C. difficile PCR assay&#xD;
&#xD;
          -  Hospitalized patient presenting with first relapse of CDI occuring between 15 and 90&#xD;
             days after an index episode of CDI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Neutropenia (absolute neutrophil count &lt;1000/microliters)&#xD;
&#xD;
          -  Contraindication for retention enema&#xD;
&#xD;
          -  Food allergy not controlled in the donor diet&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Becky Smith, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NorthShore University HealthSystem</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jennifer Grant, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NorthShore University HealthSystem</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NorthShore University HealthSystem</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Dallal RM, Harbrecht BG, Boujoukas AJ, Sirio CA, Farkas LM, Lee KK, Simmons RL. Fulminant Clostridium difficile: an underappreciated and increasing cause of death and complications. Ann Surg. 2002 Mar;235(3):363-72. doi: 10.1097/00000658-200203000-00008.</citation>
    <PMID>11882758</PMID>
  </reference>
  <reference>
    <citation>Dubberke ER, Reske KA, Olsen MA, McDonald LC, Fraser VJ. Short- and long-term attributable costs of Clostridium difficile-associated disease in nonsurgical inpatients. Clin Infect Dis. 2008 Feb 15;46(4):497-504. doi: 10.1086/526530.</citation>
    <PMID>18197759</PMID>
  </reference>
  <reference>
    <citation>Kuijper EJ, Coignard B, Tull P; ESCMID Study Group for Clostridium difficile; EU Member States; European Centre for Disease Prevention and Control. Emergence of Clostridium difficile-associated disease in North America and Europe. Clin Microbiol Infect. 2006 Oct;12 Suppl 6:2-18. doi: 10.1111/j.1469-0691.2006.01580.x.</citation>
    <PMID>16965399</PMID>
  </reference>
  <reference>
    <citation>Loo VG, Poirier L, Miller MA, Oughton M, Libman MD, Michaud S, Bourgault AM, Nguyen T, Frenette C, Kelly M, Vibien A, Brassard P, Fenn S, Dewar K, Hudson TJ, Horn R, Rene P, Monczak Y, Dascal A. A predominantly clonal multi-institutional outbreak of Clostridium difficile-associated diarrhea with high morbidity and mortality. N Engl J Med. 2005 Dec 8;353(23):2442-9. doi: 10.1056/NEJMoa051639. Epub 2005 Dec 1. Erratum In: N Engl J Med. 2006 May 18;354(20):2200.</citation>
    <PMID>16322602</PMID>
  </reference>
  <reference>
    <citation>McDonald LC, Owings M, Jernigan DB. Clostridium difficile infection in patients discharged from US short-stay hospitals, 1996-2003. Emerg Infect Dis. 2006 Mar;12(3):409-15. doi: 10.3201/eid1205.051064.</citation>
    <PMID>16704777</PMID>
  </reference>
  <reference>
    <citation>Musher DM, Aslam S, Logan N, Nallacheru S, Bhaila I, Borchert F, Hamill RJ. Relatively poor outcome after treatment of Clostridium difficile colitis with metronidazole. Clin Infect Dis. 2005 Jun 1;40(11):1586-90. doi: 10.1086/430311. Epub 2005 Apr 25.</citation>
    <PMID>15889354</PMID>
  </reference>
  <reference>
    <citation>Pepin J, Valiquette L, Alary ME, Villemure P, Pelletier A, Forget K, Pepin K, Chouinard D. Clostridium difficile-associated diarrhea in a region of Quebec from 1991 to 2003: a changing pattern of disease severity. CMAJ. 2004 Aug 31;171(5):466-72. doi: 10.1503/cmaj.1041104.</citation>
    <PMID>15337727</PMID>
  </reference>
  <reference>
    <citation>Brandt LJ, Aroniadis OC. An overview of fecal microbiota transplantation: techniques, indications, and outcomes. Gastrointest Endosc. 2013 Aug;78(2):240-9. doi: 10.1016/j.gie.2013.03.1329. Epub 2013 May 2. No abstract available.</citation>
    <PMID>23642791</PMID>
  </reference>
  <reference>
    <citation>Konijeti GG, Sauk J, Shrime MG, Gupta M, Ananthakrishnan AN. Cost-effectiveness of competing strategies for management of recurrent Clostridium difficile infection: a decision analysis. Clin Infect Dis. 2014 Jun;58(11):1507-14. doi: 10.1093/cid/ciu128. Epub 2014 Mar 31.</citation>
    <PMID>24692533</PMID>
  </reference>
  <reference>
    <citation>Chang JY, Antonopoulos DA, Kalra A, Tonelli A, Khalife WT, Schmidt TM, Young VB. Decreased diversity of the fecal Microbiome in recurrent Clostridium difficile-associated diarrhea. J Infect Dis. 2008 Feb 1;197(3):435-8. doi: 10.1086/525047.</citation>
    <PMID>18199029</PMID>
  </reference>
  <reference>
    <citation>Gough E, Shaikh H, Manges AR. Systematic review of intestinal microbiota transplantation (fecal bacteriotherapy) for recurrent Clostridium difficile infection. Clin Infect Dis. 2011 Nov;53(10):994-1002. doi: 10.1093/cid/cir632.</citation>
    <PMID>22002980</PMID>
  </reference>
  <reference>
    <citation>Kassam Z, Lee CH, Yuan Y, Hunt RH. Fecal microbiota transplantation for Clostridium difficile infection: systematic review and meta-analysis. Am J Gastroenterol. 2013 Apr;108(4):500-8. doi: 10.1038/ajg.2013.59. Epub 2013 Mar 19.</citation>
    <PMID>23511459</PMID>
  </reference>
  <reference>
    <citation>Hamilton MJ, Weingarden AR, Sadowsky MJ, Khoruts A. Standardized frozen preparation for transplantation of fecal microbiota for recurrent Clostridium difficile infection. Am J Gastroenterol. 2012 May;107(5):761-7. doi: 10.1038/ajg.2011.482. Epub 2012 Jan 31.</citation>
    <PMID>22290405</PMID>
  </reference>
  <reference>
    <citation>Youngster I, Sauk J, Pindar C, Wilson RG, Kaplan JL, Smith MB, Alm EJ, Gevers D, Russell GH, Hohmann EL. Fecal microbiota transplant for relapsing Clostridium difficile infection using a frozen inoculum from unrelated donors: a randomized, open-label, controlled pilot study. Clin Infect Dis. 2014 Jun;58(11):1515-22. doi: 10.1093/cid/ciu135. Epub 2014 Apr 23.</citation>
    <PMID>24762631</PMID>
  </reference>
  <reference>
    <citation>Kelly CR, Kunde SS, Khoruts A. Guidance on preparing an investigational new drug application for fecal microbiota transplantation studies. Clin Gastroenterol Hepatol. 2014 Feb;12(2):283-8. doi: 10.1016/j.cgh.2013.09.060. Epub 2013 Oct 6.</citation>
    <PMID>24107393</PMID>
  </reference>
  <reference>
    <citation>Cohen SH, Gerding DN, Johnson S, Kelly CP, Loo VG, McDonald LC, Pepin J, Wilcox MH; Society for Healthcare Epidemiology of America; Infectious Diseases Society of America. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the society for healthcare epidemiology of America (SHEA) and the infectious diseases society of America (IDSA). Infect Control Hosp Epidemiol. 2010 May;31(5):431-55. doi: 10.1086/651706.</citation>
    <PMID>20307191</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <results_first_submitted>November 11, 2022</results_first_submitted>
  <results_first_submitted_qc>February 1, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 3, 2023</results_first_posted>
  <last_update_submitted>February 1, 2023</last_update_submitted>
  <last_update_submitted_qc>February 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>NorthShore University HealthSystem</investigator_affiliation>
    <investigator_full_name>Jennifer Grant</investigator_full_name>
    <investigator_title>Hospital Epidemiologist</investigator_title>
  </responsible_party>
  <keyword>CDI</keyword>
  <keyword>C difficile</keyword>
  <keyword>C diff</keyword>
  <keyword>Clostridium difficile</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Clostridium Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Infective Agents</mesh_term>
    <mesh_term>Anti-Bacterial Agents</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 11, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT02255305/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>FMT Group (Intervention Arm)</title>
          <description>Patients randomized to the FMT group will have antimicrobials targeting C. difficile discontinued at least 6 hours prior to undergoing an FMT via retention enema. A second FMT via retention enema will be administered at 24 hours if diarrhea persists.&#xD;
FMT: Patients in the FMT group will receive ~50 grams of fecal material suspended in bacteriostatic normal saline and glycerol.</description>
        </group>
        <group group_id="P2">
          <title>Antimicrobial Group (Control Arm)</title>
          <description>Patients randomized to the antimicrobial group will be treated with antibiotics targeting C. difficile according to the Society for Healthcare Epidemiology of America (SHEA) Clinical Practice Guidelines for CDI. FMT will be offered to this group after 90 days if they experience relapsing CDI.&#xD;
Antimicrobials: Patients randomized to the control group will receive antimicrobials targeting C. difficile.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>FMT Group (Intervention Arm)</title>
          <description>Patients randomized to the FMT group will have antimicrobials targeting C. difficile discontinued at least 6 hours prior to undergoing an FMT via retention enema. A second FMT via retention enema will be administered at 24 hours if diarrhea persists.&#xD;
FMT: Patients in the FMT group will receive ~50 grams of fecal material suspended in bacteriostatic normal saline and glycerol.</description>
        </group>
        <group group_id="B2">
          <title>Antimicrobial Group (Control Arm)</title>
          <description>Patients randomized to the antimicrobial group will be treated with antibiotics targeting C. difficile according to the Society for Healthcare Epidemiology of America (SHEA) Clinical Practice Guidelines for CDI. FMT will be offered to this group after 90 days if they experience relapsing CDI.&#xD;
Antimicrobials: Patients randomized to the control group will receive antimicrobials targeting C. difficile.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2"/>
            <count group_id="B2" value="4"/>
            <count group_id="B3" value="6"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="89.5" spread="9.5"/>
                    <measurement group_id="B2" value="79.75" spread="24.9"/>
                    <measurement group_id="B3" value="83" spread="21.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients With Clinical Resolution of Diarrhea</title>
        <description>Number of patients with resolution of diarrhea and other abdominal symptoms or return to baseline symptoms that were present prior to C. difficile diagnosis</description>
        <time_frame>90 days</time_frame>
        <population>One patient in the control arm was lost to follow-up before the 30-day check in period</population>
        <group_list>
          <group group_id="O1">
            <title>FMT Group (Intervention Arm)</title>
            <description>Patients randomized to the FMT group will have antimicrobials targeting C. difficile discontinued at least 6 hours prior to undergoing an FMT via retention enema. A second FMT via retention enema will be administered at 24 hours if diarrhea persists.&#xD;
FMT: Patients in the FMT group will receive ~50 grams of fecal material suspended in bacteriostatic normal saline and glycerol.</description>
          </group>
          <group group_id="O2">
            <title>Antimicrobial Group (Control Arm)</title>
            <description>Patients randomized to the antimicrobial group will be treated with antibiotics targeting C. difficile according to the Society for Healthcare Epidemiology of America (SHEA) Clinical Practice Guidelines for CDI. FMT will be offered to this group after 90 days if they experience relapsing CDI.&#xD;
Antimicrobials: Patients randomized to the control group will receive antimicrobials targeting C. difficile.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Clinical Resolution of Diarrhea</title>
          <description>Number of patients with resolution of diarrhea and other abdominal symptoms or return to baseline symptoms that were present prior to C. difficile diagnosis</description>
          <population>One patient in the control arm was lost to follow-up before the 30-day check in period</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Clinical Resolution of Symptoms</title>
        <description>Amount of time it takes for patient to have cessation of diarrhea and abdominal pain/gastrointestinal symptoms (or return to baseline) and normalization of white blood cell count, creatinine, and temperature.</description>
        <time_frame>90 days</time_frame>
        <population>Unable to calculate time to clinical resolution as patients did not experience clinical resolution or lost to follow-up</population>
        <group_list>
          <group group_id="O1">
            <title>FMT Group (Intervention Arm)</title>
            <description>Patients randomized to the FMT group will have antimicrobials targeting C. difficile discontinued at least 6 hours prior to undergoing an FMT via retention enema. A second FMT via retention enema will be administered at 24 hours if diarrhea persists.&#xD;
FMT: Patients in the FMT group will receive ~50 grams of fecal material suspended in bacteriostatic normal saline and glycerol.</description>
          </group>
          <group group_id="O2">
            <title>Antimicrobial Group (Control Arm)</title>
            <description>Patients randomized to the antimicrobial group will be treated with antibiotics targeting C. difficile according to the Society for Healthcare Epidemiology of America (SHEA) Clinical Practice Guidelines for CDI. FMT will be offered to this group after 90 days if they experience relapsing CDI.&#xD;
Antimicrobials: Patients randomized to the control group will receive antimicrobials targeting C. difficile.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Clinical Resolution of Symptoms</title>
          <description>Amount of time it takes for patient to have cessation of diarrhea and abdominal pain/gastrointestinal symptoms (or return to baseline) and normalization of white blood cell count, creatinine, and temperature.</description>
          <population>Unable to calculate time to clinical resolution as patients did not experience clinical resolution or lost to follow-up</population>
          <units>days</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Length of Stay</title>
        <description>Patients' length of stay post-procedure will be measured</description>
        <time_frame>90 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FMT Group (Intervention Arm)</title>
            <description>Patients randomized to the FMT group will have antimicrobials targeting C. difficile discontinued at least 6 hours prior to undergoing an FMT via retention enema. A second FMT via retention enema will be administered at 24 hours if diarrhea persists.&#xD;
FMT: Patients in the FMT group will receive ~50 grams of fecal material suspended in bacteriostatic normal saline and glycerol.</description>
          </group>
          <group group_id="O2">
            <title>Antimicrobial Group (Control Arm)</title>
            <description>Patients randomized to the antimicrobial group will be treated with antibiotics targeting C. difficile according to the Society for Healthcare Epidemiology of America (SHEA) Clinical Practice Guidelines for CDI. FMT will be offered to this group after 90 days if they experience relapsing CDI.&#xD;
Antimicrobials: Patients randomized to the control group will receive antimicrobials targeting C. difficile.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Length of Stay</title>
          <description>Patients' length of stay post-procedure will be measured</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22" spread="18.4"/>
                    <measurement group_id="O2" value="6.5" spread="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Hospital Readmission</title>
        <description>Number of patients re-admitted to the hospital for recurrent Clostridium difficile infection</description>
        <time_frame>90 days</time_frame>
        <population>One patient in the control arm was lost to follow-up before the 30-day check in period</population>
        <group_list>
          <group group_id="O1">
            <title>FMT Group (Intervention Arm)</title>
            <description>Patients randomized to the FMT group will have antimicrobials targeting C. difficile discontinued at least 6 hours prior to undergoing an FMT via retention enema. A second FMT via retention enema will be administered at 24 hours if diarrhea persists.&#xD;
FMT: Patients in the FMT group will receive ~50 grams of fecal material suspended in bacteriostatic normal saline and glycerol.</description>
          </group>
          <group group_id="O2">
            <title>Antimicrobial Group (Control Arm)</title>
            <description>Patients randomized to the antimicrobial group will be treated with antibiotics targeting C. difficile according to the Society for Healthcare Epidemiology of America (SHEA) Clinical Practice Guidelines for CDI. FMT will be offered to this group after 90 days if they experience relapsing CDI.&#xD;
Antimicrobials: Patients randomized to the control group will receive antimicrobials targeting C. difficile.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Hospital Readmission</title>
          <description>Number of patients re-admitted to the hospital for recurrent Clostridium difficile infection</description>
          <population>One patient in the control arm was lost to follow-up before the 30-day check in period</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mortality</title>
        <description>Number of patients who died from any cause within 90 days of randomization</description>
        <time_frame>90 days</time_frame>
        <population>One patient in the control arm was lost to follow-up before the 30-day check in period</population>
        <group_list>
          <group group_id="O1">
            <title>FMT Group (Intervention Arm)</title>
            <description>Patients randomized to the FMT group will have antimicrobials targeting C. difficile discontinued at least 6 hours prior to undergoing an FMT via retention enema. A second FMT via retention enema will be administered at 24 hours if diarrhea persists.&#xD;
FMT: Patients in the FMT group will receive ~50 grams of fecal material suspended in bacteriostatic normal saline and glycerol.</description>
          </group>
          <group group_id="O2">
            <title>Antimicrobial Group (Control Arm)</title>
            <description>Patients randomized to the antimicrobial group will be treated with antibiotics targeting C. difficile according to the Society for Healthcare Epidemiology of America (SHEA) Clinical Practice Guidelines for CDI. FMT will be offered to this group after 90 days if they experience relapsing CDI.&#xD;
Antimicrobials: Patients randomized to the control group will receive antimicrobials targeting C. difficile.</description>
          </group>
        </group_list>
        <measure>
          <title>Mortality</title>
          <description>Number of patients who died from any cause within 90 days of randomization</description>
          <population>One patient in the control arm was lost to follow-up before the 30-day check in period</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>FMT Group (Intervention Arm)</title>
          <description>Patients randomized to the FMT group will have antimicrobials targeting C. difficile discontinued at least 6 hours prior to undergoing an FMT via retention enema. A second FMT via retention enema will be administered at 24 hours if diarrhea persists.&#xD;
FMT: Patients in the FMT group will receive ~50 grams of fecal material suspended in bacteriostatic normal saline and glycerol.</description>
        </group>
        <group group_id="E2">
          <title>Antimicrobial Group (Control Arm)</title>
          <description>Patients randomized to the antimicrobial group will be treated with antibiotics targeting C. difficile according to the Society for Healthcare Epidemiology of America (SHEA) Clinical Practice Guidelines for CDI. FMT will be offered to this group after 90 days if they experience relapsing CDI.&#xD;
Antimicrobials: Patients randomized to the control group will receive antimicrobials targeting C. difficile.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <description>Transient (&lt; 24 hours) or intermittent nausea with no or minimal interference with oral intake</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="6" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <description>Transient or intermittent episodes of unformed stools OR Increase of ≤ 3 stools over baseline per 24-hour period</description>
                <counts group_id="E1" events="17" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E2" events="17" subjects_affected="4" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <description>Transient or intermittent vomiting with no or minimal interference with oral intake</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Abdominal distention or bloating</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="7" subjects_affected="3" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Colitis Symptoms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fever</sub_title>
                <description>(99.9-100.5°F)</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Fatigue/Malaise</sub_title>
                <description>Symptoms causing no or minimal interference with usual social &amp; functional activities</description>
                <counts group_id="E1" events="18" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E2" events="9" subjects_affected="4" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Weight Loss</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <description>Symptoms causing no or minimal interference with usual social &amp; functional activities</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Study ended early due to personnel needed for study completion (enrollment, follow-up, FMT procedure) and did not reach enrollment goals.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Jennifer Grant</name_or_title>
      <organization>NorthShore UH</organization>
      <phone>847-570-2420</phone>
      <email>jgrant@northshore.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02255305
org study id: EH 14-331
nct id: NCT02255305
lead sponsor: 
has dmc: Yes
The purpose of the study is to determine the safety and efficacy of Fecal Microbiota
      Transplant (FMT) for the treatment of the recurrence of Clostridium difficile infection (CDI)
      as compared to standard antibiotic therapy. Patients who have tested positive for CDI within
      90 days of an admission for relapse of CDI will be approached to participate in this
      open-label, randomized controlled trial. Patients will either be randomized to the
      intervention group (receive FMT via retention enema) or the control group (receive
      antimicrobials targeting CDI).
This trial is an open-label, randomized, controlled trial evaluating the safety and efficacy
      of fecal microbiota transplantation (FMT) for the treatment of the recurrence of Clostridium
      difficile infection (CDI) as compared to standard antibiotic therapy. Clostridium difficile
      infection (CDI) has increased in incidence and severity over the last decade and is
      associated with poor outcomes including increased morbidity, mortality, and healthcare costs
      (1-8). Relapse occurs in 15-35% of patients after the first episode of CDI and 45-65% of
      patients who have one relapse will experience a subsequent relapse (9, 10). Dysbiosis -
      decreased diversity of the fecal microbiome - is thought to contribute to the high rate of
      relapse (11). FMT quickly and successfully restores normal intestinal microorganisms of the
      diseased patient via infusion of a liquid stool preparation from a healthy donor. FMT
      resulted in disease resolution in ~90% of cases reported in a systematic review and
      meta-analyses without any significant adverse events noted (12, 13).

      All hospitalized patients in the NorthShore system >18 years of age who are diagnosed with
      active CDI, defined as >3 diarrheal stools per day and a positive C. difficile polymerase
      chain reaction (PCR) assay, will be evaluated for inclusion in the study. Hospitalized
      patients presenting with their first or greater relapse of CDI occurring between 15 and 90
      days after an index episode of CDI will be eligible for enrollment. Exclusion criteria will
      include pregnancy, neutropenia (absolute neutrophil count <1000/μl), contraindication for
      retention enema, or food allergy not controlled for in the donor diet. Eligible patients will
      undergo written informed consent followed by randomization into intervention and control
      groups.

      Patients who are randomized to the intervention group will have antimicrobials targeting C.
      difficile discontinued at least 6 hours prior to undergoing an FMT via retention enema. A
      second FMT via retention enema will be administered at 24 hours if diarrhea persists.
      Patients randomized to the control group will be treated with antimicrobials targeting C.
      difficile according to the Society for Healthcare Epidemiology of America Clinical Practice
      Guidelines for CDI (18). FMT will be offered to the control group after 90 days if they
      experience relapsing CDI.

      Two healthy "universal" donors who have previously donated fecal material for FMT have
      expressed willingness to participate in the study. Donors will complete the American
      Association of Blood Banks donor questionnaire for exposure to infectious agents as well as
      undergo serologic and stool testing for communicable diseases or pathogenic bacteria/viruses
      as previously described (17).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Patients With Clinical Resolution of Diarrhea
time frame: 90 days
description: Number of patients with resolution of diarrhea and other abdominal symptoms or return to baseline symptoms that were present prior to C. difficile diagnosis
measure: Time to Clinical Resolution of Symptoms
time frame: 90 days
description: Amount of time it takes for patient to have cessation of diarrhea and abdominal pain/gastrointestinal symptoms (or return to baseline) and normalization of white blood cell count, creatinine, and temperature.
measure: Hospital Length of Stay
time frame: 90 days
description: Patients' length of stay post-procedure will be measured
measure: Number of Patients With Hospital Readmission
time frame: 90 days
description: Number of patients re-admitted to the hospital for recurrent Clostridium difficile infection
measure: Mortality
time frame: 90 days
description: Number of patients who died from any cause within 90 days of randomization
arm group label: FMT Group (Intervention Arm)
arm group type: Experimental
description: Patients randomized to the FMT group will have antimicrobials targeting C. difficile discontinued at least 6 hours prior to undergoing an FMT via retention enema. A second FMT via retention enema will be administered at 24 hours if diarrhea persists.
arm group label: Antimicrobial Group (Control Arm)
arm group type: Active Comparator
description: Patients randomized to the antimicrobial group will be treated with antibiotics targeting C. difficile according to the Society for Healthcare Epidemiology of America (SHEA) Clinical Practice Guidelines for CDI. FMT will be offered to this group after 90 days if they experience relapsing CDI.
intervention type: Biological
intervention name: FMT
description: Patients in the FMT group will receive ~50 grams of fecal material suspended in bacteriostatic normal saline and glycerol.
arm group label: FMT Group (Intervention Arm)
other name: Fecal Microbiota Transplant
other name: Stool Transplant
intervention type: Drug
intervention name: Antimicrobials
description: Patients randomized to the control group will receive antimicrobials targeting C. difficile.
arm group label: Antimicrobial Group (Control Arm)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Becky Smith, MD
role: Principal Investigator
affiliation: NorthShore University HealthSystem
last name: Jennifer Grant, MD
role: Principal Investigator
affiliation: NorthShore University HealthSystem
facility: 
country: United States
citation: Dallal RM, Harbrecht BG, Boujoukas AJ, Sirio CA, Farkas LM, Lee KK, Simmons RL. Fulminant Clostridium difficile: an underappreciated and increasing cause of death and complications. Ann Surg. 2002 Mar;235(3):363-72. doi: 10.1097/00000658-200203000-00008.
PMID: 11882758
citation: Dubberke ER, Reske KA, Olsen MA, McDonald LC, Fraser VJ. Short- and long-term attributable costs of Clostridium difficile-associated disease in nonsurgical inpatients. Clin Infect Dis. 2008 Feb 15;46(4):497-504. doi: 10.1086/526530.
PMID: 18197759
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responsible party type: Principal Investigator
investigator affiliation: NorthShore University HealthSystem
investigator full name: Jennifer Grant
investigator title: Hospital Epidemiologist
mesh term: Infections
mesh term: Clostridium Infections
mesh term: Anti-Infective Agents
mesh term: Anti-Bacterial Agents
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study ended early due to personnel needed for study completion (enrollment, follow-up, FMT procedure) and did not reach enrollment goals.
point of contact: 