<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/NCT03834051</url>
  </required_header>
  <id_info>
    <org_study_id>GID.FMT</org_study_id>
    <nct_id>NCT03834051</nct_id>
  </id_info>
  <brief_title>Fecal Microbiota Transplantation for Treatment of Gastrointestinal Dysbiosis Clearance of ARO</brief_title>
  <acronym>FMTGID</acronym>
  <official_title>Prospective, Open-label Trial to Evaluate Efficacy of Fecal Microbiota Transplantation for Treatment of Chronic Gastrointestinal Dysbiosis or Clearance of Antimicrobial Resistant Organism.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vancouver Island Health Authority</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vancouver Island Health Authority</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to assess the efficacy of FMTs via enema for 1) symptom&#xD;
      improvement in individuals with a formal diagnosis of dysbiosis due to active inflammatory&#xD;
      bowel disease or irritable bowel syndrome; 2) clearance of antimicrobial resistant organism&#xD;
      from the gastrointestinal tract.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Since the formal implementation of fecal microbiota transplantation trials at St. Joseph's&#xD;
      Healthcare Hamilton in 2012, there are daily phone calls and e-mails from patients with a&#xD;
      variety of chronic gastrointestinal disorders such as ulcerative colitis, Crohns, chronic&#xD;
      irritable bowel syndrome, chronic severe constipation due to dysbiosis, which are formally&#xD;
      diagnosed by gastroenterologists who specialize in this disorder to request for FMT. Out of&#xD;
      desperation, some of these patients have explored the option of performing FMT at home.&#xD;
&#xD;
      There are instructions on how to manufacture and perform home FMTs on the internet. Given&#xD;
      this some patients may perform FMTs at home using stool samples from unscreened and/or&#xD;
      inappropriate donors. Individuals with metabolic disorders, family history of colonic cancer,&#xD;
      autoimmune disease, gastrointestinal disorders as well as the ones whose blood and stools are&#xD;
      unscreened should be excluded from donating stools. Unsupervised and using stool samples from&#xD;
      an unscreened or unsuitable donor can lead to undesirable immediate and long-term&#xD;
      consequences. The real possibility of these patients performing FMTs at home using stool&#xD;
      samples from unscreened donors is very concerning.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">August 2020</completion_date>
  <primary_completion_date type="Anticipated">August 2020</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>Treatment</measure>
    <time_frame>2 years</time_frame>
    <description>Symptom improvement in formal diagnosis of dysbiosis or clearance of antimicrobial resistant organism</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Dysbiosis</condition>
  <condition>Antimicrobial Resistant Organism</condition>
  <arm_group>
    <arm_group_label>Open Label</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fecal Microbiota Transplantation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fecal Microbiota Transplantation</intervention_name>
    <description>Fecal Microbiota Transplantation Enema Open Label</description>
    <arm_group_label>Open Label</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older.&#xD;
&#xD;
          -  Able to provide informed consent.&#xD;
&#xD;
          -  Willing and able to comply with all the required study procedures.&#xD;
&#xD;
          -  Rectally colonized with antimicrobial resistant organisms: Extended-spectrum of&#xD;
             beta-lactamase, Carbapenem resistant, vancomycin resistant enterococci&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Planned or actively taking another investigational product&#xD;
&#xD;
          -  Patients with neutropenia with absolute neutrophil count &lt;0.5 x 109/L&#xD;
&#xD;
          -  Evidence of toxic megacolon or gastrointestinal perforation on abdominal x-ray&#xD;
&#xD;
          -  Peripheral white blood cell count &gt; 30.0 x 109/L AND temperature &gt; 38.0 ºC&#xD;
&#xD;
          -  Active gastroenteritis due to Salmonella, Shigella, E. coli 0157H7, Yersinia or&#xD;
             Campylobacter.&#xD;
&#xD;
          -  Unable to tolerate FMT or enema for any reason.&#xD;
&#xD;
          -  Requiring systemic antibiotic therapy at the time of FMT.&#xD;
&#xD;
          -  Actively taking Saccharomyces boulardii or other probiotic; yogurt is allowed&#xD;
&#xD;
          -  Severe underlying disease such that the patient is not expected to survive for at&#xD;
             least 30 days.&#xD;
&#xD;
          -  History of severe allergy to any food&#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>Christine Lee</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vancouver Island Health Authority</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vancouver Island Health Authority</name>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <zip>V8R 1J8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>January 23, 2020</last_update_submitted>
  <last_update_submitted_qc>January 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vancouver Island Health Authority</investigator_affiliation>
    <investigator_full_name>Christine Lee</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dysbiosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>January 27, 2022</submitted>
    <returned>March 30, 2022</returned>
    <submitted>April 27, 2022</submitted>
    <submission_canceled>April 29, 2022</submission_canceled>
    <submitted>September 28, 2022</submitted>
    <returned>August 15, 2023</returned>
    <submitted>August 24, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03834051
org study id: GID.FMT
nct id: NCT03834051
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to assess the efficacy of FMTs via enema for 1) symptom
      improvement in individuals with a formal diagnosis of dysbiosis due to active inflammatory
      bowel disease or irritable bowel syndrome; 2) clearance of antimicrobial resistant organism
      from the gastrointestinal tract.
Since the formal implementation of fecal microbiota transplantation trials at St. Joseph's
      Healthcare Hamilton in 2012, there are daily phone calls and e-mails from patients with a
      variety of chronic gastrointestinal disorders such as ulcerative colitis, Crohns, chronic
      irritable bowel syndrome, chronic severe constipation due to dysbiosis, which are formally
      diagnosed by gastroenterologists who specialize in this disorder to request for FMT. Out of
      desperation, some of these patients have explored the option of performing FMT at home.

      There are instructions on how to manufacture and perform home FMTs on the internet. Given
      this some patients may perform FMTs at home using stool samples from unscreened and/or
      inappropriate donors. Individuals with metabolic disorders, family history of colonic cancer,
      autoimmune disease, gastrointestinal disorders as well as the ones whose blood and stools are
      unscreened should be excluded from donating stools. Unsupervised and using stool samples from
      an unscreened or unsuitable donor can lead to undesirable immediate and long-term
      consequences. The real possibility of these patients performing FMTs at home using stool
      samples from unscreened donors is very concerning.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Treatment
time frame: 2 years
description: Symptom improvement in formal diagnosis of dysbiosis or clearance of antimicrobial resistant organism
arm group label: Open Label
arm group type: Experimental
description: Fecal Microbiota Transplantation
intervention type: Drug
intervention name: Fecal Microbiota Transplantation
description: Fecal Microbiota Transplantation Enema Open Label
arm group label: Open Label
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christine Lee
role: Principal Investigator
affiliation: Vancouver Island Health Authority
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Vancouver Island Health Authority
investigator full name: Christine Lee
investigator title: MD
mesh term: Dysbiosis
sharing ipd: No
submitted: January 27, 2022
returned: March 30, 2022
submitted: April 27, 2022
submission canceled: April 29, 2022
submitted: September 28, 2022
returned: August 15, 2023
submitted: August 24, 2023