<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/NCT01704937</url>
  </required_header>
  <id_info>
    <org_study_id>2012-P-001657</org_study_id>
    <nct_id>NCT01704937</nct_id>
  </id_info>
  <brief_title>Fecal Microbiota Transplant (FMT) for Relapsing C. Difficile Infection in Adults and Children Using a Frozen Inoculum</brief_title>
  <official_title>Fecal Microbiota Transplant (FMT) for Relapsing C. Difficile Infection in Adults and Children Using a Frozen Inoculum</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fecal microbiota transplantation (FMT) is the reconstitution of normal flora by a &quot;stool&#xD;
      transplant&quot; from a healthy individual to a C. difficile-infected recipient, and has long been&#xD;
      a successful approach to recurrent/refractory C. difficile. The purpose of this project is to&#xD;
      generate a frozen FMT inoculum from well-screened healthy volunteer donors which can be used&#xD;
      repeatedly, particularly in those who do not have a healthy intimate partner or other related&#xD;
      donor. Delivery of FMT has been performed colonoscopically, by fecal retention enema, or by&#xD;
      the nasogastric route. This study will evaluate the safety and secondarily the efficacy of a&#xD;
      frozen inoculum administered by nasogastric tube vs administered by colonoscope.&#xD;
&#xD;
      Subjects with recurrent/relapsing C. difficile infection (10 per group) will receive FMT via&#xD;
      either:&#xD;
&#xD;
        -  colonoscopy&#xD;
&#xD;
        -  NGT&#xD;
&#xD;
      The primary endpoint is assessment of safety as measured by clinical events (GI, procedural,&#xD;
      systemic). Efficacy will be defined as a resolution of diarrhea off antibiotics for C.&#xD;
      difficile, in the absence of a need for OTHER systemic antibiotics, i.e. resumption of a&#xD;
      normal bowel status for the individual. Secondary efficacy endpoints include weight,&#xD;
      subjective well-being and relative clinical improvement per standardized questionnaire, and&#xD;
      subject qualitative assessment of, and satisfaction with, the transplant procedures. Subjects&#xD;
      will be monitored for clinical safety by history and standard exams and the follow-up&#xD;
      questionnaire as well as followed closely by phone and in person.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>Phase 1</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>Safety</measure>
    <time_frame>up to 6 mo post FMT</time_frame>
    <description>Safety is assessed by clinical symptoms, exam, signs (GI and systemic)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy</measure>
    <time_frame>3 months</time_frame>
    <description>Efficacy is defined as resolution of C. Difficile signs and symptoms off antibiotics for C. difficile</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Clostridium Difficile Infection</condition>
  <arm_group>
    <arm_group_label>Colonoscopy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fecal microbiota transplant (&quot;stool transplant&quot;) from healthy, unrelated donor via colonoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nasogastric Tube (NGT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fecal microbiota transplant (&quot;stool transplant&quot;) from healthy, unrelated donor via NGT</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fecal Microbiota Transplant (FMT)</intervention_name>
    <description>Reconstitution of normal flora by a &quot;stool transplant&quot; from a healthy individual to a C. difficile - infected recipient via colonoscopy or nasogastric tube</description>
    <arm_group_label>Colonoscopy</arm_group_label>
    <arm_group_label>Nasogastric Tube (NGT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with recurrent or relapsing CDI defined as EITHER(13):&#xD;
&#xD;
               -  At least three episodes of mild-to-moderate CDI and failure of a 6-8 week taper&#xD;
                  with vancomycin with or without an alternative antibiotic (e.g. rifaximin,&#xD;
                  nitazoxanide).&#xD;
&#xD;
               -  At least two episodes of severe CDI resulting in hospitalization and associated&#xD;
                  with significant morbidity.&#xD;
&#xD;
          -  Willingness to accept risk of unrelated donor stool&#xD;
&#xD;
          -  Willingness to be randomized to NGT vs. colonoscopic delivery.&#xD;
&#xD;
          -  Able to consent for self, or parental assent/child assent as age appropriate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anatomic contraindication to NGT&#xD;
&#xD;
          -  Delayed gastric emptying syndrome&#xD;
&#xD;
          -  Known chronic aspiration&#xD;
&#xD;
          -  Contraindication to colonoscopy (ASA 4 or more)&#xD;
&#xD;
          -  High risk of bacterial translocation (Immunosuppression, cirrhosis etc)&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Acute unrelated infection or comorbid illness exaccerbation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth L Hohmann, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_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>
  </results_reference>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>June 18, 2014</last_update_submitted>
  <last_update_submitted_qc>June 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Elizabeth L. Hohmann, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Fecal Microbiota Transplant</keyword>
  <keyword>Clostridium difficile</keyword>
  <keyword>Diarrhea</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Clostridium Infections</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01704937
org study id: 2012-P-001657
nct id: NCT01704937
lead sponsor: 
has dmc: No
Fecal microbiota transplantation (FMT) is the reconstitution of normal flora by a "stool
      transplant" from a healthy individual to a C. difficile-infected recipient, and has long been
      a successful approach to recurrent/refractory C. difficile. The purpose of this project is to
      generate a frozen FMT inoculum from well-screened healthy volunteer donors which can be used
      repeatedly, particularly in those who do not have a healthy intimate partner or other related
      donor. Delivery of FMT has been performed colonoscopically, by fecal retention enema, or by
      the nasogastric route. This study will evaluate the safety and secondarily the efficacy of a
      frozen inoculum administered by nasogastric tube vs administered by colonoscope.

      Subjects with recurrent/relapsing C. difficile infection (10 per group) will receive FMT via
      either:

        -  colonoscopy

        -  NGT

      The primary endpoint is assessment of safety as measured by clinical events (GI, procedural,
      systemic). Efficacy will be defined as a resolution of diarrhea off antibiotics for C.
      difficile, in the absence of a need for OTHER systemic antibiotics, i.e. resumption of a
      normal bowel status for the individual. Secondary efficacy endpoints include weight,
      subjective well-being and relative clinical improvement per standardized questionnaire, and
      subject qualitative assessment of, and satisfaction with, the transplant procedures. Subjects
      will be monitored for clinical safety by history and standard exams and the follow-up
      questionnaire as well as followed closely by phone and in person.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety
time frame: up to 6 mo post FMT
description: Safety is assessed by clinical symptoms, exam, signs (GI and systemic)
measure: Efficacy
time frame: 3 months
description: Efficacy is defined as resolution of C. Difficile signs and symptoms off antibiotics for C. difficile
arm group label: Colonoscopy
arm group type: Experimental
description: Fecal microbiota transplant ("stool transplant") from healthy, unrelated donor via colonoscopy
arm group label: Nasogastric Tube (NGT)
arm group type: Experimental
description: Fecal microbiota transplant ("stool transplant") from healthy, unrelated donor via NGT
intervention type: Drug
intervention name: Fecal Microbiota Transplant (FMT)
description: Reconstitution of normal flora by a "stool transplant" from a healthy individual to a C. difficile - infected recipient via colonoscopy or nasogastric tube
arm group label: Colonoscopy
arm group label: Nasogastric Tube (NGT)
criteria: 
gender: All
minimum age: 7 Years
maximum age: 90 Years
healthy volunteers: No
last name: Elizabeth L Hohmann, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
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.
PMID: 24762631
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Elizabeth L. Hohmann, MD
investigator title: Principal Investigator
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Clostridium Infections