Status:
COMPLETED
Fecal Microbiota Transplantation (FMT) in the Management of Active Ulcerative Colitis
Lead Sponsor:
University of Alberta
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Manipulation of the intestinal microbiota through FMT is a potential therapeutic target for IBD patients. Studies are now required to determine if repeated FMT can overcome the apparent immune respons...
Detailed Description
same as above
Eligibility Criteria
Inclusion
- Age \> 18 and \< 65 years
- Diagnosis of UC for \> 3 months but \< 5 years prior to screening as determined by the investigators
- Those with mild to moderate UC
- Those who have failed maintenance therapy with stable doses of 5-ASA, azathioprine or 6 mercaptopurine (6-MP) 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 or 6-MP must be at a stable dose for \> 8 weeks
- ability to provide informed consent
- evidence of active inflammation
Exclusion
- Those whose disease is limited to the rectum (ie. proctitis)
- Those with colectomy or diverting ileostomy
- 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 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
- Those with colonic mucosal dysplasia
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
NCT02227342
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