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Fecal Microbiota Transplantation (FMT) in the Management of Active Crohn's Disease

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ClinicalTrials.gov Identifier: NCT02199561
Recruitment Status : Completed
First Posted : July 24, 2014
Last Update Posted : December 14, 2016
Sponsor:
Information provided by (Responsible Party):
Dina Kao, University of Alberta

Tracking Information
First Submitted Date  ICMJE July 22, 2014
First Posted Date  ICMJE July 24, 2014
Last Update Posted Date December 14, 2016
Study Start Date  ICMJE July 2014
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2014)
HBI score reduction [ Time Frame: 12 and 32 weeks ]
Patients with at least 3 point reduction in HBI scores at week 12 and at week 32 in the extension phase.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02199561 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fecal Microbiota Transplantation (FMT) in the Management of Active Crohn's Disease
Official Title  ICMJE A Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Active Crohn's Disease
Brief Summary Manipulation of the intestinal microbiota through FMT is a potential therapeutic target for CD patients. Studies are now required to determine if repeated FMT can overcome the apparent immune response to FMT thereby maintaining sustained clinical improvement and remission. Prior to a large randomized controlled trial of FMT in CD we will carry out a feasibility study to determine if serial FMTs can sustain a clinical response and maintain stability of transplanted microbiota.
Detailed Description Participants receive FMT by colonoscopy at Weeks 0, 4, 8 and by enema at Weeks 2 and 6. Assessments include HBI score, SES-CD score, and serum CRP levels.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE Biological: Fecal Microbiota Transplant
Fecal transplant processed from routinely screened universal donor
Study Arms  ICMJE Experimental: Fecal Microbiota Transplant
Open label single arm delivering fecal transplant to each participant
Intervention: Biological: Fecal Microbiota Transplant
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 Completed
Actual Enrollment  ICMJE
 (submitted: May 5, 2016)
3
Original Estimated Enrollment  ICMJE
 (submitted: July 22, 2014)
20
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age > 18 and < 65 years at the time of screening
  2. Diagnosis of ileo-colonic or colonic CD for > 3 months but < 5 years prior to screening as determined by the investigators
  3. Those with mild to moderate CD
  4. Those who have failed maintenance therapy with stable doses of 5-ASA, azathioprine, 6 mercaptopurine (6-MP) or methotrexate for > 3 months
  5. Where applicable, those who are taking the following medications must be at a stable dose defined as:

    i) 5-ASA must be at a stable dose for 2 weeks ii) Prednisone up to 20 mg/d must be at a stable dose for 2 weeks iii) Budesonide up to 6 mg/d must be at a stable dose for 2 weeks iv) Azathioprine, 6-MP, and methotrexate must be at a stable dose for > 8 weeks

  6. ability to provide informed consent
  7. evidence of active colonic inflammation

Exclusion Criteria:

  1. Those with prior ileo-cecal resection
  2. Those who are pregnancy or plan to be pregnant during the trial
  3. Those who are breastfeeding or plan to breast feed during the trial
  4. Those who are on or have previously failed a biological agent
  5. Those who have active perianal disease as determined by investigators
  6. Those with an active infection requiring antibiotic therapy
  7. Those with positive stool cultures for known pathogens such as E coli, Salmonella, Shigella, Yersinia, Campylobacter, and Clostridium difficile toxin within 2 weeks of enrollment
  8. Those with positive CMV on colonic tissue biopsy within 2 weeks of screening
  9. Those with allergy to ciprofloxacin and metronidazole
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02199561
Other Study ID Numbers  ICMJE 47055
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dina Kao, University of Alberta
Study Sponsor  ICMJE University of Alberta
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dina Kao, MD University of Alberta
PRS Account University of Alberta
Verification Date December 2016

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