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

February 5, 2021 updated by: Microbiome Health Research Institute

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

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.

Study Overview

Status

Terminated

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Naperville, Illinois, United States, 60540
        • Edward Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • IU University Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02108
        • Tufts Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • Brown University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult (age 18-75 years old)
  • 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 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 10^9/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

    • HIV infection (any CD4 count)
    • AIDS-defining diagnoses
    • Inherited/primary immune disorder
    • Immunosuppressant medications:
  • Current or recent (<3 months) treatment with anti-neoplastic agents
  • Current or recent (<3 months) treatment with calcineurin inhibitors (tacrolimus, cyclosporine)
  • Current or recent (<3 months) treatment with mycophenolate mofetil
  • Current or recent (<3 months) treatment with monoclonal antibodies to B and T-Cells, anti-TNF, glucocorticoids, antimetabolites (azathioprine, 6-mercaptopurine)
  • Neutropenia with absolute neutrophil count (ANC) <0.5 x 10^9/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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention: Fecal Microbiota Preparation

Open label single arm Dosage form: Screened human donor stool, sourced from human-derived microbes generated by healthy, screened donors.

Route of administration: either colonoscopic/sigmoidoscopic FMT or retention enema FMT Dosing Regimen: 250 mL x 1 dose. In the event of a clinical non-response, a repeat single 250 mL dose will occur from a different donor

Frozen processed human fecal material for treating recurrent Clostridium difficile infections.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-term Safety of FMT as Measured by Absence or Presence of Related Serious Adverse Events
Time Frame: < 6 weeks post FMT
Determine the short-term safety of FMT for the prevention of further CDI recurrence. Short-term safety was measured by absence or presence of related serious adverse events
< 6 weeks post FMT
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
> 6 weeks to 1 year post FMT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

March 6, 2015

First Submitted That Met QC Criteria

March 25, 2015

First Posted (Estimate)

March 31, 2015

Study Record Updates

Last Update Posted (Actual)

February 23, 2021

Last Update Submitted That Met QC Criteria

February 5, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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