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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT02058524
First received: August 27, 2013
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Ulcerative Colitis
Biological: fecal microbiota transplantation
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Comparison of microbiome pre and post transplant [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Tolerability of colonoscopic FMT on Day 0 and Day 7 assessed by Tolerability Questionnaire


Estimated Enrollment: 20
Study Start Date: June 2013
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fecal microbiota transplantation Biological: fecal microbiota transplantation
Other Name: FMT

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02058524

Contacts
Contact: Stacy Kahn, MD (773) 702-3552 skahn@peds.bsd.uchicago.edu
Contact: David Rubin, MD (773) 702-2950 drubin@medicine.bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago Medicine Recruiting
Chicago, Illinois, United States, 60637
Contact: Sarah R. Goeppinger    773-702-5055    sgoeppinger@medicine.bsd.uchicago.edu   
Contact: Stacy A. Kahn, MD    (773) 702-6418    skahn@peds.bsd.uchicago.edu   
Principal Investigator: Stacy Kahn, MD         
Principal Investigator: David Rubin, MD         
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Stacy Kahn, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02058524     History of Changes
Other Study ID Numbers: IRB13-0212
Study First Received: August 27, 2013
Last Updated: February 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Chicago:
Ulcerative Colitis
Fecal Microbiota Transplantation

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014