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

NCT ID: NCT02058524

Last Updated: 2016-08-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2016-06-30

Brief Summary

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.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

fecal microbiota transplantation

Group Type: EXPERIMENTAL

fecal microbiota transplantation

Intervention Type: BIOLOGICAL

Interventions

fecal microbiota transplantation

Intervention Type: BIOLOGICAL

Other Intervention Names

FMT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stacy Kahn, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago Medicine

Chicago, Illinois, United States

Countries

United States

Other Identifiers

IRB13-0212

Identifier Type: -

Identifier Source: org_study_id