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

Primary Purpose

Clostridium Difficile

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fecal Microbiota Preparation
Sponsored by
Microbiome Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridium Difficile

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Edward Hospital
  • IU University Hospital
  • Tufts Medical Center
  • Brown University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention: Fecal Microbiota Preparation

Arm Description

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

Outcomes

Primary Outcome Measures

Short-term Safety of FMT as Measured by Absence or Presence of Related Serious Adverse Events
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
Long-term Safety of FMT as Measured by Absence or Presence of Adverse Events
Determine the long-term safety of FMT for the prevention of further CDI recurrence

Secondary Outcome Measures

Full Information

First Posted
March 6, 2015
Last Updated
February 5, 2021
Sponsor
Microbiome Health Research Institute
Collaborators
Brown University, Edward Hospital, Indiana University, Tufts Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02403622
Brief Title
Safety of FMT: OpenBiome Outcomes and Longitudinal Follow-up (STOOL) for Recurrent Clostridium Difficile Infection
Acronym
STOOL
Official Title
Safety of Fecal Microbiota Transplantation: OpenBiome Outcomes and Longitudinal Follow-up (STOOL) for Recurrent Clostridium Difficile Infection
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
for futility
Study Start Date
March 2015 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Microbiome Health Research Institute
Collaborators
Brown University, Edward Hospital, Indiana University, Tufts Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention: Fecal Microbiota Preparation
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Fecal Microbiota Preparation
Intervention Description
Frozen processed human fecal material for treating recurrent Clostridium difficile infections.
Primary Outcome Measure Information:
Title
Short-term Safety of FMT as Measured by Absence or Presence of Related Serious Adverse Events
Description
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
Time Frame
< 6 weeks post FMT
Title
Long-term Safety of FMT as Measured by Absence or Presence of Adverse Events
Description
Determine the long-term safety of FMT for the prevention of further CDI recurrence
Time Frame
> 6 weeks to 1 year post FMT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Edward Hospital
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Facility Name
IU University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02108
Country
United States
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02904
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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