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

NCT02058524 | Terminated Phase 1 DMC

• 1 other identifier: IRB13-0212
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Keywords

Ulcerative Colitis; Fecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (1)

• Comparison of microbiome pre and post transplant

  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.

  12 weeks

Secondary Outcomes (2)

• Adverse event frequency

  6 months

• Tolerance of procedure

  day 0 and day 7

Study Arms (1)

fecal microbiota transplantation

EXPERIMENTAL

Biological: fecal microbiota transplantation

Interventions

fecal microbiota transplantation BIOLOGICAL

Also known as: FMT

fecal microbiota transplantation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Stacy Kahn, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2013
• First Posted: February 10, 2014
• Study Start: June 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 24, 2016

Record last verified: 2016-08

Locations

US (1)