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

Clostridium Difficile Clinical Trial

— STOOL  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02403622
• Other study ID #: 1410006671
• Status: Terminated
• Phase: Phase 2
• Start date: March 2015
• Est. completion date: June 2018

Study information

• Verified date: February 2021
• Source: Microbiome Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: June 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile
• Clostridium Infections

Intervention

Drug:
• Fecal Microbiota Preparation
Frozen processed human fecal material for treating recurrent Clostridium difficile infections.

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts
United States	IU University Hospital	Indianapolis	Indiana
United States	Edward Hospital	Naperville	Illinois
United States	Brown University	Providence	Rhode Island

Sponsors (5)

Lead Sponsor	Collaborator
Microbiome Health Research Institute	Brown University, Edward Hospital, Indiana University, Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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