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

A Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Active Ulcerative Colitis

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Biological: Fecal Microbiota Transplant

Detailed Description

same as above

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • University of Alberta Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fecal Microbiota Transplantation; serial Fecal Microbiota Transplantation	Biological: Fecal Microbiota Transplant; serial FMT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mayo score reduction	Patients with at least 3 point reduction in partial Mayo scoring index at week 12 and at week 32 in the extension phase.	12 and 32 weeks

Collaborators and Investigators

• Sponsor: University of Alberta

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: July 22, 2014
• First Submitted That Met QC Criteria: August 26, 2014
• First Posted (Estimate): August 28, 2014

Study Record Updates

• Last Update Posted (Estimate): December 14, 2016
• Last Update Submitted That Met QC Criteria: December 13, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 47056