Clinical trial NCT02199561: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Crohn's Disease
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2014-07-24
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: HBI score reduction
timeFrame: 12 and 32 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Dina Kao, MD
role: PRINCIPAL_INVESTIGATOR
References: