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

The University of Chicago

Status and phase

Terminated

Phase 1

Conditions

Ulcerative Colitis

Treatments

Biological: fecal microbiota transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT02058524

IRB13-0212

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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