Status:
COMPLETED
Fecal Microbiota Transplantation (FMT) in the Management of Active Crohn's Disease
Lead Sponsor:
University of Alberta
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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...
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.
Eligibility Criteria
Inclusion
- Age \> 18 and \< 65 years at the time of screening
- Diagnosis of ileo-colonic or colonic CD for \> 3 months but \< 5 years prior to screening as determined by the investigators
- Those with mild to moderate CD
- Those who have failed maintenance therapy with stable doses of 5-ASA, azathioprine, 6 mercaptopurine (6-MP) or methotrexate for \> 3 months
- 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
- ability to provide informed consent
- evidence of active colonic inflammation
Exclusion
- Those with prior ileo-cecal resection
- Those who are pregnancy or plan to be pregnant during the trial
- Those who are breastfeeding or plan to breast feed during the trial
- Those who are on or have previously failed a biological agent
- Those who have active perianal disease as determined by investigators
- Those with an active infection requiring antibiotic therapy
- 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
- Those with positive CMV on colonic tissue biopsy within 2 weeks of screening
- Those with allergy to ciprofloxacin and metronidazole
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT02199561
Start Date
July 1 2014
End Date
December 1 2016
Last Update
December 14 2016
Active Locations (1)
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1
University of Alberta Hospital
Edmonton, Alberta, Canada