- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02403622
Safety of FMT: OpenBiome Outcomes and Longitudinal Follow-up (STOOL) for Recurrent Clostridium Difficile Infection (STOOL)
Safety of Fecal Microbiota Transplantation: OpenBiome Outcomes and Longitudinal Follow-up (STOOL) for Recurrent Clostridium Difficile Infection
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Illinois
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Naperville, Illinois, United States, 60540
- Edward Hospital
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Indiana
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Indianapolis, Indiana, United States, 46202
- IU University Hospital
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Massachusetts
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Boston, Massachusetts, United States, 02108
- Tufts Medical Center
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Rhode Island
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Providence, Rhode Island, United States, 02904
- Brown University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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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
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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
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< 6 weeks post FMT
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Long-term Safety of FMT as Measured by Absence or Presence of Adverse Events
Time Frame: > 6 weeks to 1 year post FMT
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Determine the long-term safety of FMT for the prevention of further CDI recurrence
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> 6 weeks to 1 year post FMT
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1410006671
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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