Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02403622
Recruitment Status : Terminated (for futility)
First Posted : March 31, 2015
Last Update Posted : November 16, 2018
Sponsor:
Collaborators:
Brown University
Edward Hospital
University of Virginia
Indiana University
MOUNT SINAI HOSPITAL
Montefiore Medical Center
Tufts Medical Center
University of Utah
Information provided by (Responsible Party):
Microbiome Health Research Institute

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 Phase
Clostridium Difficile Drug: Fecal Microbiota Preparations Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety of Fecal Microbiota Transplantation: OpenBiome Outcomes and Longitudinal Follow-up (STOOL) for Recurrent Clostridium Difficile Infection
Actual Study Start Date : March 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: intervention
open label single arm
Drug: Fecal Microbiota Preparations
Frozen processed human fecal material for treating recurrent clostridium difficile infections.




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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


Locations
Layout table for location information
United States, Illinois
Edward Hospital
Naperville, Illinois, United States, 60540
United States, Indiana
IU University Hospital
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02108
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Mount Sinai Hospital
New York, New York, United States, 10029
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02904
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Microbiome Health Research Institute
Brown University
Edward Hospital
University of Virginia
Indiana University
MOUNT SINAI HOSPITAL
Montefiore Medical Center
Tufts Medical Center
University of Utah
Investigators
Layout table for investigator information
Principal Investigator: Zain Kassam, MD, MPH OpenBiome

Layout table for additonal 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: November 16, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections