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

NCT ID: NCT02199561

Last Updated: 2016-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-12-31

Brief 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.

Detailed 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.

Conditions

Crohn's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fecal Microbiota Transplant

Open label single arm delivering fecal transplant to each participant

Group Type: EXPERIMENTAL

Fecal Microbiota Transplant

Intervention Type: BIOLOGICAL

Fecal transplant processed from routinely screened universal donor

Interventions

Fecal Microbiota Transplant

Fecal transplant processed from routinely screened universal donor

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Dina Kao

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dina Kao, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta Hospital

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

47055

Identifier Type: -

Identifier Source: org_study_id