Overview

This trial is active, not recruiting.

Condition crohn's disease
Treatment fecal microbiota transplant
Phase phase 1/phase 2
Sponsor University of Alberta
Start date July 2014
End date December 2016
Trial size 3 participants
Trial identifier NCT02199561, 47055

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Open label single arm delivering fecal transplant to each participant
fecal microbiota transplant
Fecal transplant processed from routinely screened universal donor

Primary Outcomes

Measure
HBI score reduction
time frame: 12 and 32 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title A Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Active Crohn's Disease
Principal investigator Dina Kao, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Alberta.