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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02227342
• Other study ID #: 47056
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 22, 2014
• Last updated: December 13, 2016
• Start date: July 2014
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

same as above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Biological:
• Fecal Microbiota Transplant
serial FMT

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No