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

NCT02227342 | Completed Phase 1 DMC

• 1 other identifier: 47056
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Fecal Microbiota Transplantation

EXPERIMENTAL

serial Fecal Microbiota Transplantation

Biological: Fecal Microbiota Transplant

Interventions

Fecal Microbiota Transplant BIOLOGICAL

serial FMT

Fecal Microbiota Transplantation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Dina Kao, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: August 28, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 14, 2016

Record last verified: 2016-12

Locations

CA (1)