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

NCT02403622 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 1410006671
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 4

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.

Conditions

Clostridium Difficile

Outcome Measures

Primary Outcomes (2)

• 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

  < 6 weeks post FMT

• 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

  > 6 weeks to 1 year post FMT

Study Arms (1)

Intervention: Fecal Microbiota Preparation

EXPERIMENTAL

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

Drug: Fecal Microbiota Preparation

Interventions

Fecal Microbiota Preparation DRUG

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

Intervention: Fecal Microbiota Preparation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Microbiome Health Research Institute: lead
• Brown University: collaborator
• Edward Hospital: collaborator
• Indiana University: collaborator
• Tufts Medical Center: collaborator

Study Sites (4)

Edward Hospital

Naperville, Illinois, 60540, United States

Location

IU University Hospital

Indianapolis, Indiana, 46202, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02108, United States

Location

Brown University

Providence, Rhode Island, 02904, United States

Location

Results Point of Contact

• Title: Majdi Osman, MD, MPH
• Organization: Microbiome Health Research Institute

mosman@openbiome.org

6175752201

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2015
• First Posted: March 31, 2015
• Study Start: March 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: June 1, 2018
• Last Updated: February 23, 2021
• Results First Posted: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)