Back to resultsFecal Microbiota Transplantation (FMT) in the Management of Active Crohn's Disease
Primary Purpose
Crohn's Disease
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Fecal Microbiota Transplant
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease
Eligibility Criteria
Inclusion Criteria:
- Age > 18 and < 65 years at the time of screening
- Diagnosis of ileo-colonic or colonic CD for > 3 months but < 5 years prior to screening as determined by the investigators
- Those with mild to moderate CD
- Those who have failed maintenance therapy with stable doses of 5-ASA, azathioprine, 6 mercaptopurine (6-MP) or methotrexate 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, 6-MP, and methotrexate must be at a stable dose for > 8 weeks
- ability to provide informed consent
- evidence of active colonic inflammation
Exclusion Criteria:
- Those with prior ileo-cecal resection
- 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 who have active perianal disease as determined by investigators
- 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
Sites / Locations
- University of Alberta Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fecal Microbiota Transplant
Arm Description
Open label single arm delivering fecal transplant to each participant
Outcomes
Primary Outcome Measures
HBI score reduction
Patients with at least 3 point reduction in HBI scores at week 12 and at week 32 in the extension phase.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02199561
Brief Title
Fecal Microbiota Transplantation (FMT) in the Management of Active Crohn's Disease
Official Title
A Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Active Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fecal Microbiota Transplant
Arm Type
Experimental
Arm Description
Open label single arm delivering fecal transplant to each participant
Intervention Type
Biological
Intervention Name(s)
Fecal Microbiota Transplant
Intervention Description
Fecal transplant processed from routinely screened universal donor
Primary Outcome Measure Information:
Title
HBI score reduction
Description
Patients with at least 3 point reduction in HBI scores at week 12 and at week 32 in the extension phase.
Time Frame
12 and 32 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 and < 65 years at the time of screening
Diagnosis of ileo-colonic or colonic CD for > 3 months but < 5 years prior to screening as determined by the investigators
Those with mild to moderate CD
Those who have failed maintenance therapy with stable doses of 5-ASA, azathioprine, 6 mercaptopurine (6-MP) or methotrexate 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, 6-MP, and methotrexate must be at a stable dose for > 8 weeks
ability to provide informed consent
evidence of active colonic inflammation
Exclusion Criteria:
Those with prior ileo-cecal resection
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 who have active perianal disease as determined by investigators
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dina Kao, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Fecal Microbiota Transplantation (FMT) in the Management of Active Crohn's Disease
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