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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02058524
Recruitment Status : Terminated (Unable to recruit and enroll eligible subjects.)
First Posted : February 10, 2014
Last Update Posted : August 24, 2016
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Biological: fecal microbiota transplantation Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis
Study Start Date : June 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: fecal microbiota transplantation Biological: fecal microbiota transplantation
Other Name: FMT


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of microbiome pre and post transplant [ Time Frame: 12 weeks ]
    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 :
  1. Adverse event frequency [ Time Frame: 6 months ]
    Number of patients with reporting adverse events with type and severity of adverse events reported

  2. Tolerance of procedure [ Time Frame: day 0 and day 7 ]
    Tolerability of colonoscopic FMT on Day 0 and Day 7 assessed by Tolerability Questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02058524


Locations
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United States, Illinois
University of Chicago Medicine
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Stacy Kahn, MD University of Chicago
More Information
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02058524    
Other Study ID Numbers: IRB13-0212
First Posted: February 10, 2014    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016
Keywords provided by University of Chicago:
Ulcerative Colitis
Fecal Microbiota Transplantation
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases