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Safety of FMT: OpenBiome Outcomes and Longitudinal Follow-up (STOOL) for Recurrent Clostridium Difficile Infection (STOOL)

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ClinicalTrials.gov Identifier: NCT02403622
Recruitment Status : Recruiting
First Posted : March 31, 2015
Last Update Posted : July 4, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
The overarching objective of this study is to address the knowledge gap regarding the short-term and long-term safety of fecal microbiota transplants (FMT). The design will be a prospective, open-label, multi-center longitudinal cohort study to assess the short- and long-term safety of FMT as well as the clinical resolution of diarrhea among 150 patients with 3 or more episodes of clostridium difficile infection (CDI defined as 3 unformed stools over 24 hours for 2 consecutive days and either a positive stool test for CDI or pseudomembranes on colonoscopy/sigmoidoscopy). Subjects will be adult outpatients referred to one of the study centers after at least three recurrent episodes of CDI and previous treatment with at least one 10-day course of oral vancomycin or fidaxomicin. After FMT by colonoscopy/sigmoidoscopy or enema, patients will be followed prospectively and monitored for clinical resolution and adverse events at: 3 days (telephone), 3 weeks (clinical assessment), 8 weeks (telephone), 6 months (telephone), and 12 months (telephone) after FMT. Subjects who recur will be offered a second FMT by colonoscopy with a different donor. Microbiome analysis will be conducted from stool samples at baseline and each of the 5 follow-up intervals.

Condition or disease Intervention/treatment
Clostridium Difficile Drug: Fecal Microbiota Preparations

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety of Fecal Microbiota Transplantation: OpenBiome Outcomes and Longitudinal Follow-up (STOOL) for Recurrent Clostridium Difficile Infection
Study Start Date : March 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Drug: Fecal Microbiota Preparations
    Frozen processed human fecal material for treating recurrent clostridium difficile infections.

Outcome Measures

Primary Outcome Measures :
  1. Short-term safety of FMT as measured by absence or presence of adverse events [ Time Frame: < 6 weeks post FMT ]
    Determine the short-term safety of FMT for the prevention of further CDI recurrence

  2. Long-term safety of FMT as measured by absence or presence of adverse events [ Time Frame: > 6 weeks to 1 year post FMT ]
    Determine the long-term safety of FMT for the prevention of further CDI recurrence

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult outpatients with third or further documented CDI episode.

Inclusion Criteria:

  • Adult (at least 18 years of age)
  • Outpatient
  • Third or further documented CDI episode and
  • Unable to maintain CDI cure after standard therapy with oral vancomycin or fidaxomicin

    • Previous treatment with at least one course of tapered/pulse vancomycin or
    • Inability to taper or stop vancomycin or fidaxomicin without developing diarrhea requiring antibiotic therapy.
  • Improvement of CDI symptoms on vancomycin or fidaxomicin

Exclusion Criteria:

  • Unable to comply with study follow-up procedures or travel to clinical site for follow-up visits at discretion of MD
  • Unable to provide informed consent at discretion of MD
  • Participating in another clinical trial
  • Pregnant or nursing currently or planned pregnancy in next 1 year
  • Evidence of toxic megacolon or gastrointestinal perforation
  • Peripheral white blood cell count >30 x 109/L and/or temperature >38 degrees Celsius
  • Admission to an intensive care unit within prior 7 days for any reason
  • Previously undergone FMT
  • Severely immunocompromised patients

    o Documented history (self- or physician identified) HIV infection with any cluster of differentiation 4 (CD4) count

    • AIDS-defining diagnoses
    • Inherited/primary immune disorder
    • Immunosuppressant medications
  • Neutropenia with absolute neutrophil count (ANC) <0.5 x 109/L
  • Active gastroenteritis due to infectious cause other than CDI
  • Short gut syndrome
  • Colostomy
  • Ascites
  • End-stage liver disease
  • Untreated, in-situ colorectal cancer
  • Irritable bowel syndrome
  • Inflammatory bowel disease including Crohn's disease and ulcerative colitis
  • Microscopic colitis including collagenous colitis and lymphocytic colitis
  • Severe food allergy (anaphylaxis) that cannot be confirmed as having been excluded from a donor's diet within the five days prior to donation
  • Anorectal disorder/severe rectal sphincter tone abnormality or inability to retain enema material
  • Unable or unwilling to tolerate colonoscopy/sigmoidoscopy, colonoscopy prep, or enema for any reason at discretion of MD
  • Severe underlying disease that the patient is not expected to survive for the subsequent 12 months at the discretion of the MD.
  • Any conditions for which, in opinion of MD, the treatment may pose a health risk
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02403622

Contact: Zain Kassam, MD, MPH 617-575-2201 ext 700 zain@openbiome.org
Contact: Robyn Day, AB 617-575-2201 ext 725 robyn@openbiome.org

United States, Illinois
Edward Hospital Recruiting
Naperville, Illinois, United States, 60540
Contact: Darren Kastin, MD         
Principal Investigator: Darren Kastin, MD         
United States, Indiana
IU University Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Monika Fischer, MD         
Principal Investigator: Monika Fischer, MD         
United States, Massachusetts
Tufts Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02108
Contact: Aaron Dickstein, MD         
Principal Investigator: Aaron Dickstein, MD         
United States, New York
Montefiore Medical Center Not yet recruiting
Bronx, New York, United States, 10467
Contact: Olga Aroniadis, MD         
Principal Investigator: Olga Aroniadis, MD         
Mount Sinai Hospital Not yet recruiting
New York, New York, United States, 10029
Contact: Ari Grinspan, MD         
Principal Investigator: Ari Grinspan, MD         
United States, Rhode Island
Brown University Recruiting
Providence, Rhode Island, United States, 02904
Contact: Colleen Kelly, MD         
Principal Investigator: Colleen Kelly, MD         
United States, Utah
University of Utah Not yet recruiting
Salt Lake City, Utah, United States, 84132
Contact: Ann Flynn, MD         
Principal Investigator: Ann Flynn, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Anne Hays, MD         
Principal Investigator: Anne Hays, MD         
Sponsors and Collaborators
Microbiome Health Research Institute
Brown University
Edward Hospital
University of Virginia
Indiana University
Mount Sinai Hospital, New York
Montefiore Medical Center
Tufts Medical Center
University of Utah
Principal Investigator: Zain Kassam, MD, MPH OpenBiome
More Information

Responsible Party: Microbiome Health Research Institute
ClinicalTrials.gov Identifier: NCT02403622     History of Changes
Other Study ID Numbers: 1410006671
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: July 4, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No