Fecal Microbiota Transplantation (FMT) in the Management of Active Ulcerative Colitis

Phase 1

Completed

• Conditions: Ulcerative Colitis
• Interventions: Biological: Fecal Microbiota Transplant

• Registration Number: NCT02227342
• Lead Sponsor: University of Alberta

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

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-22
• Study First Submitted QC: 2014-08-26
• Study First Posted: 2014-08-28
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-13
• Last Update Posted: 2016-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fecal Microbiota Transplantation	Fecal Microbiota Transplant	serial Fecal Microbiota Transplantation

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada