Ulcerative Colitis
Conditions
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 response to FMT thereby maintaining sustained clinical improvement and remission. Prior to a large randomized controlled trial of FMT in UC 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
same as above
Interventions
BIOLOGICALFecal Microbiota Transplant
serial FMT
Sponsors
University of Alberta
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age \> 18 and \< 65 years 2. Diagnosis of UC for \> 3 months but \< 5 years prior to screening as determined by the investigators 3. Those with mild to moderate UC 4. Those who have failed maintenance therapy with stable doses of 5-ASA, azathioprine or 6 mercaptopurine (6-MP) 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 or 6-MP must be at a stable dose for \> 8 weeks 6. ability to provide informed consent 7. evidence of active inflammation
Exclusion criteria
1. Those whose disease is limited to the rectum (ie. proctitis) 2. Those with colectomy or diverting ileostomy 3. Those who are pregnancy or plan to be pregnant during the trial 4. Those who are breastfeeding or plan to breast feed during the trial 5. Those who are on or have previously failed a biological agent 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 10. Those with colonic mucosal dysplasia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mayo score reduction | 12 and 32 weeks | Patients with at least 3 point reduction in partial Mayo scoring index at week 12 and at week 32 in the extension phase. |
Countries
Canada
Outcome results
None listed