A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis
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ClinicalTrials.gov Identifier: NCT02058524
Recruitment Status :
(Unable to recruit and enroll eligible subjects.)
The investigators are conducting an open-label study of fecal microbiota transplantation (FMT) for adult patients with mildly-moderately active ulcerative colitis. In this pilot study the investigators will evaluate the feasibility, safety, and tolerability of a single application of FMT delivered colonoscopically. The investigators will also characterize the impact of FMT on the microbiota of the recipient and determine if it correlates with the microbiota from the FMT donor.
Comparison of microbiome pre and post transplant [ Time Frame: 12 weeks ]
We will analyze and compare the microbiome (bacterial populations) present pre- and post- transplant of the recipient. We will also analyze the microbiome of the donor and compare it to the donor microbiome pre- and post-FMT.
Secondary Outcome Measures :
Adverse event frequency [ Time Frame: 6 months ]
Number of patients with reporting adverse events with type and severity of adverse events reported
Tolerance of procedure [ Time Frame: day 0 and day 7 ]
Tolerability of colonoscopic FMT on Day 0 and Day 7 assessed by Tolerability Questionnaire
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Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Men or women, aged 18-65 years old
Prior endoscopic confirmation of UC:
Mildly to moderately active UC with Simple Clinical Colitis Activity Index (SCCAI) activity index >4-9
Failing standard therapy with:
stable doses of 5-ASA >2 weeks; thiopurines >3 months; or is steroid dependent at a dose <20mg/d; (inability to taper off steroid for longer than 1 week)
Stable medications dose for at least 2 weeks prior to screening and upon entry into trial
Ability to understand and willingness to sign informed consent document
Diagnosis of Crohn's disease, indeterminate colitis, or proctitis alone
Severe or fulminate colitis
Women who are pregnant or nursing
Patients who are unable to give informed consent
Patients who are unable or unwilling to undergo colonoscopy
Patients who have previously undergone FMT
Patients who have a confirmed malignancy or cancer
Patients who are immunocompromised
Treatment within last 12 weeks with cyclosporine, tacrolimus, infliximab, adalimumab, certolizumab, natalizumab, thalidomide
Antibiotic use within 2-months of start date
Participation in a clinical trial in the preceding 30 days or simultaneously during this trial
Probiotic use within 30 days of start date
Rectal therapy within 14 days of start date
Congenital or acquired immunodeficiencies
Other comorbidities including:
Diabetes mellitus, cancer, systemic lupus, must be able to tolerate conscious sedation with colonoscopy
Chronic kidney disease as defined by a GFR <60mL/min/1.73m2 (40)
History of rheumatic heart disease, endocarditis, or valvular disease due to risk of bacteremia.
Positive screening and confirmatory tests for HIV 1 & 2, Hepatitis A, B, & C, and Syphilis