Fecal Microbiota Transplantation (FMT) in the Management of Active Crohn's Disease

Crohn's Disease Clinical Trial

Official title:

A Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Active Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02199561
• Other study ID #: 47055
• 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: Institutional Review BoardCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Manipulation of the intestinal microbiota through FMT is a potential therapeutic target for CD 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 CD we will carry out a feasibility study to determine if serial FMTs can sustain a clinical response and maintain stability of transplanted microbiota.

Description:

Participants receive FMT by colonoscopy at Weeks 0, 4, 8 and by enema at Weeks 2 and 6. Assessments include HBI score, SES-CD score, and serum CRP levels.

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 at the time of screening

2. Diagnosis of ileo-colonic or colonic CD for > 3 months but < 5 years prior to screening as determined by the investigators

3. Those with mild to moderate CD

4. Those who have failed maintenance therapy with stable doses of 5-ASA, azathioprine, 6 mercaptopurine (6-MP) or methotrexate 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, 6-MP, and methotrexate must be at a stable dose for > 8 weeks

6. ability to provide informed consent

7. evidence of active colonic inflammation

Exclusion Criteria:

1. Those with prior ileo-cecal resection

2. Those who are pregnancy or plan to be pregnant during the trial

3. Those who are breastfeeding or plan to breast feed during the trial

4. Those who are on or have previously failed a biological agent

5. Those who have active perianal disease as determined by investigators

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

Study Design

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Biological:
• Fecal Microbiota Transplant
Fecal transplant processed from routinely screened universal donor

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	HBI score reduction	Patients with at least 3 point reduction in HBI scores at week 12 and at week 32 in the extension phase.	12 and 32 weeks	No