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

Stopped early · Phase 2

Conditions studied: Clostridium Difficile

In brief

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.

Key facts

Study ID

NCT02403622

Run by

Microbiome Health Research Institute

People needed

17

Starts

2015-03-01

Expected to finish

2018-06-01

Last updated by the study team

2021-02-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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)
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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