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

Study Overview
=================
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.

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

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Biological: Fecal Microbiota Transplant


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fecal Microbiota Transplant<br>Open label single arm delivering fecal transplant to each participant | Biological: Fecal Microbiota Transplant<br>* Fecal transplant processed from routinely screened universal donor<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |