<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/NCT02968511</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00005388</org_study_id>
    <nct_id>NCT02968511</nct_id>
  </id_info>
  <brief_title>EGESTA - Emergent GI Therapy for Severe, Complicated CDI Using Fecal Microbiota Transplant</brief_title>
  <acronym>EGESTA</acronym>
  <official_title>EGESTA - Emergent GI Therapy for Severe, Complicated CDI Using Fecal Microbiota</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Milton S. Hershey Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>OpenBiome</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Milton S. Hershey Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives/specific aims of this study are three-fold. First, the study seeks to evaluate&#xD;
      the safety of fecal microbiota transplant (FMT) in patients with severe, complicated C.&#xD;
      difficile infection (scCDI). Second, the study seeks to evaluate whether fecal microbiota&#xD;
      transplant (FMT) can improve scCDI, with &quot;improve&quot; defined as either decreasing the severity&#xD;
      of CDI, or by resolving the infection altogether. Third, the study seeks to further study the&#xD;
      mechanism by which FMT improves the course of scCDI by performing 16S rRNA and ITS sequencing&#xD;
      on pre-FMT and serial post-FMT stool samples in order to measure changes to bacterial and&#xD;
      fungal microbiota as a consequence of CDI and FMT therapy. FMT material (hereafter referred&#xD;
      to as FMTm) would be obtained from OpenBiome. FMTm is prepared from prescreened healthy&#xD;
      donors.&#xD;
&#xD;
      The hypothesis of the study is that FMT is a preferred salvage therapy for scCDI as compared&#xD;
      to (1) ongoing, failing medical therapy with conventional antibiotics and (2) surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objectives/specific aims of this study are three-fold. First, the study seeks to evaluate&#xD;
      the safety of fecal microbiota transplant (FMT) in patients with severe, complicated C.&#xD;
      difficile infection (scCDI). Second, the study seeks to evaluate whether fecal microbiota&#xD;
      transplant (FMT) can improve scCDI, with &quot;improve&quot; defined as either decreasing the severity&#xD;
      of CDI, or by resolving the infection altogether. Third, the study seeks to further study the&#xD;
      mechanism by which FMT improves the course of scCDI by performing 16S rRNA and ITS sequencing&#xD;
      on pre-FMT and serial post-FMT stool samples in order to measure changes to bacterial and&#xD;
      fungal microbiota as a consequence of CDI and FMT therapy. FMT material (hereafter referred&#xD;
      to as FMTm) would be obtained from OpenBiome. FMTm is prepared from prescreened healthy&#xD;
      donors.&#xD;
&#xD;
      The hypothesis of the study is that FMT is a preferred salvage therapy for scCDI as compared&#xD;
      to (1) ongoing, failing medical therapy with conventional antibiotics and (2) surgery.&#xD;
&#xD;
      The standard of care treatment for scCDI is conventional antibiotics with either&#xD;
      parenteral/oral metronidazole, and/or vancomycin provided in the form of oral and/or&#xD;
      retention enemas. The reliability of these conventional antibiotics in the setting of scCDI&#xD;
      is very unpredictable, and patients with CDI of this severity have a mortality rate that in&#xD;
      some series is greater than 50%. It is against the mediocre historical record of these&#xD;
      antibiotics that FMT would be tested in this highly moribund patient population.&#xD;
&#xD;
      FMT would not be provided to patients with scCDI off protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Lack of eligible patients&#xD;
  </why_stopped>
  <start_date type="Actual">September 15, 2016</start_date>
  <completion_date type="Actual">November 14, 2017</completion_date>
  <primary_completion_date type="Actual">November 14, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety - adverse events</measure>
    <time_frame>Thirty days after treatment</time_frame>
    <description>Absence of unexpected related adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy (Cure of infection, or decrease in severity of infection based on white blood cell count)</measure>
    <time_frame>Thirty days after treatment</time_frame>
    <description>Cure of infection, or decrease in severity of infection based on white blood cell count</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>C.Difficile Colitis</condition>
  <arm_group>
    <arm_group_label>fecal microbiota transplant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>250 mL of fecal transplant material by enema as treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>fecal microbiota transplant</intervention_name>
    <description>Fecal microbiota transplant for the treatment of severe, complicated C. difficile infection</description>
    <arm_group_label>fecal microbiota transplant</arm_group_label>
    <other_name>FMT Microbiota Preparation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults between 18 years of age and 75 years of age.&#xD;
&#xD;
          -  Have CDI defined as clinical symptoms of CDI (diarrhea with or without abdominal&#xD;
             pain/abdominal distention) with a confirmatory nucleic acid amplification test (NAAT)&#xD;
             positive for CDI.&#xD;
&#xD;
          -  Have severe/complicated disease as defined by ACG guidelines(appendix 1), with any of&#xD;
             the following attributable to CDI:&#xD;
&#xD;
               -  Admission to intensive care unit for CDI&#xD;
&#xD;
               -  Hypotension (systolic blood pressure &lt; 90 mmHg) with or without required use of&#xD;
                  vasopressors&#xD;
&#xD;
               -  Fever ≥ 38.5 ° C&#xD;
&#xD;
               -  Ileus (as defined by the absence of intestinal function for at least 24 hours&#xD;
                  and/or radiographic evidence of pathologically dilated small intestine without&#xD;
                  evidence of a mechanical obstruction) or significant abdominal distention&#xD;
&#xD;
               -  Mental status changes&#xD;
&#xD;
               -  WBC ≥ 35,000 cells / mm 3 or &lt; 2,000 cells / mm 3&#xD;
&#xD;
               -  Serum lactate levels &gt;2.2 mmol / l&#xD;
&#xD;
               -  End organ failure (mechanical ventilation,renal failure as defined by a rise in&#xD;
                  creatinine of &gt;1.5 mg/dL either above the upper limit of normal for creatinine,&#xD;
                  or &gt; 1.5 mg/dL from premorbid levels if that information is known, acute hepatic&#xD;
                  dysfunction as defined by an increase in AST or ALT to twice the upper limit of&#xD;
                  normal, etc.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Patients under the age of 18 or over the age of 76 years of age&#xD;
&#xD;
          -  Patients who are immunocompromised including but not limited to:&#xD;
&#xD;
               -  Have HIV infection historically reported, regardless of CD4 count&#xD;
&#xD;
               -  AIDS as defined by either an AIDS-defining diagnosis (appendix 2) or a CD4 count&#xD;
                  &lt;200/mm3,&#xD;
&#xD;
               -  Inherited or primary immune disorders,&#xD;
&#xD;
               -  Received chemotherapy within the previous 90 days, or&#xD;
&#xD;
               -  Current or recent treatment with any immunosuppressant medications in the past 90&#xD;
                  days&#xD;
&#xD;
          -  Individuals who have received FMT at any time before potential study enrollment&#xD;
&#xD;
          -  Patients who do not have a stool test confirming C. difficile infection&#xD;
&#xD;
          -  Patients who have a severe anaphylactic response to food&#xD;
&#xD;
          -  Patients with allergies to sodium chloride or glycerol, both ingredients Generally&#xD;
             Recognized As Safe (GRAS)&#xD;
&#xD;
          -  Patients who have colorectal cancer&#xD;
&#xD;
          -  Diagnosis of Irritable Bowel Disease or Irritable Bowel Syndrome&#xD;
&#xD;
          -  Any other condition for which the Principal Investigator thinks the treatment may pose&#xD;
             a health risk&#xD;
&#xD;
          -  Anticipated or predicted death within the time period of follow-up for reasons&#xD;
             unrelated to CDI&#xD;
&#xD;
          -  An APACHE II score &gt;29 at the time of evaluation for inclusion in the study protocol&#xD;
             (Appendix 4.0)&#xD;
&#xD;
          -  Mandatory ongoing antibiotic use for non-CDI infection&#xD;
&#xD;
          -  Patients unable to provide informed consent or who do not have a legally authorized&#xD;
             representative for consent&#xD;
&#xD;
          -  Patients unable to comply with requirements of this study protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>David Stewart</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17078</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>November 11, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>November 22, 2017</last_update_submitted>
  <last_update_submitted_qc>November 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Milton S. Hershey Medical Center</investigator_affiliation>
    <investigator_full_name>David B. Stewart, MD, FACS, FASCRS</investigator_full_name>
    <investigator_title>Associate Professor of Surger</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02968511
org study id: STUDY00005388
nct id: NCT02968511
lead sponsor: 
collaborator: 
has dmc: Yes
The objectives/specific aims of this study are three-fold. First, the study seeks to evaluate
      the safety of fecal microbiota transplant (FMT) in patients with severe, complicated C.
      difficile infection (scCDI). Second, the study seeks to evaluate whether fecal microbiota
      transplant (FMT) can improve scCDI, with "improve" defined as either decreasing the severity
      of CDI, or by resolving the infection altogether. Third, the study seeks to further study the
      mechanism by which FMT improves the course of scCDI by performing 16S rRNA and ITS sequencing
      on pre-FMT and serial post-FMT stool samples in order to measure changes to bacterial and
      fungal microbiota as a consequence of CDI and FMT therapy. FMT material (hereafter referred
      to as FMTm) would be obtained from OpenBiome. FMTm is prepared from prescreened healthy
      donors.

      The hypothesis of the study is that FMT is a preferred salvage therapy for scCDI as compared
      to (1) ongoing, failing medical therapy with conventional antibiotics and (2) surgery.
The objectives/specific aims of this study are three-fold. First, the study seeks to evaluate
      the safety of fecal microbiota transplant (FMT) in patients with severe, complicated C.
      difficile infection (scCDI). Second, the study seeks to evaluate whether fecal microbiota
      transplant (FMT) can improve scCDI, with "improve" defined as either decreasing the severity
      of CDI, or by resolving the infection altogether. Third, the study seeks to further study the
      mechanism by which FMT improves the course of scCDI by performing 16S rRNA and ITS sequencing
      on pre-FMT and serial post-FMT stool samples in order to measure changes to bacterial and
      fungal microbiota as a consequence of CDI and FMT therapy. FMT material (hereafter referred
      to as FMTm) would be obtained from OpenBiome. FMTm is prepared from prescreened healthy
      donors.

      The hypothesis of the study is that FMT is a preferred salvage therapy for scCDI as compared
      to (1) ongoing, failing medical therapy with conventional antibiotics and (2) surgery.

      The standard of care treatment for scCDI is conventional antibiotics with either
      parenteral/oral metronidazole, and/or vancomycin provided in the form of oral and/or
      retention enemas. The reliability of these conventional antibiotics in the setting of scCDI
      is very unpredictable, and patients with CDI of this severity have a mortality rate that in
      some series is greater than 50%. It is against the mediocre historical record of these
      antibiotics that FMT would be tested in this highly moribund patient population.

      FMT would not be provided to patients with scCDI off protocol.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety - adverse events
time frame: Thirty days after treatment
description: Absence of unexpected related adverse events
measure: Efficacy (Cure of infection, or decrease in severity of infection based on white blood cell count)
time frame: Thirty days after treatment
description: Cure of infection, or decrease in severity of infection based on white blood cell count
arm group label: fecal microbiota transplant
arm group type: Experimental
description: 250 mL of fecal transplant material by enema as treatment
intervention type: Biological
intervention name: fecal microbiota transplant
description: Fecal microbiota transplant for the treatment of severe, complicated C. difficile infection
arm group label: fecal microbiota transplant
other name: FMT Microbiota Preparation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Milton S. Hershey Medical Center
investigator full name: David B. Stewart, MD, FACS, FASCRS
investigator title: Associate Professor of Surger
mesh term: Colitis
sharing ipd: No