A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis

Stopped early · Phase 1

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT02058524

Run by

University of Chicago

People needed

1

Starts

2013-06-01

Expected to finish

2016-06-01

Last updated by the study team

2016-08-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Decompensated cirrhosis
• 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.
• Steroid >20mg/day
• Positive screening and confirmatory tests for HIV 1 \& 2, Hepatitis A, B, \& C, and Syphilis

Where it is running

• University of Chicago Medicine — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.