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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

Tracking Information
First Submitted Date  ICMJE August 27, 2013
First Posted Date  ICMJE February 10, 2014
Last Update Posted Date August 24, 2016
Study Start Date  ICMJE June 2013
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02058524 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2014)
  • Adverse event frequency [ Time Frame: 6 months ]
    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 ]
    Tolerability of colonoscopic FMT on Day 0 and Day 7 assessed by Tolerability Questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis
Official Title  ICMJE A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE Biological: fecal microbiota transplantation
Other Name: FMT
Study Arms  ICMJE Experimental: fecal microbiota transplantation
Intervention: Biological: fecal microbiota transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 23, 2016)
1
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2014)
20
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02058524
Other Study ID Numbers  ICMJE IRB13-0212
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stacy Kahn, MD University of Chicago
PRS Account University of Chicago
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP