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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 September 2022
Main ID:  NCT03078803
Date of registration: 12/01/2017
Prospective Registration: Yes
Primary sponsor: University of Alberta
Public title: Fecal Transplant for Crohn's Disease
Scientific title: A Prospective Multicenter Randomized Controlled Trial Comparing Fecal Microbiota Transplantation (FMT) to Placebo in the Treatment of Mild to Moderate Crohn's Disease
Date of first enrolment: March 28, 2017
Target sample size: 38
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03078803
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 2
Countries of recruitment
Canada
Contacts
Name:     Dina Kao, MD
Address: 
Telephone:
Email:
Affiliation:  University of Alberta
Key inclusion & exclusion criteria

Inclusion Criteria:

- mild to moderate ileal, ileo-colonic or colonic Crohns disease

- active ileal and/or colonic disease on endoscopy with or without elevated inflammatory
markers i.e. C-reactive protein >8mg/L, elevated fecal calprotectin >250 ug/g

- If applicable, meds stable as follows: 5-ASA for 4 weeks, prednisone up to 20mg QD for
4 weeks, budesonide up to 6mg QD for 4 weeks, azathioprine, 6-MP and methotrexate for
12 weeks

- Use of effective contraception

Exclusion Criteria:

- Antibiotic exposure within 30 days and probiotic exposure within 14 days

- topical inflammatory bowel disease therapy within 2 weeks

- active perianal disease

- requirement for concurrent antibiotic therapy

- SES-CD score <5

- severe CD HBI >25 or need for hospitalization

- abdominal abscess

- extensive colonic resection, subtotal or total colectomy

- ileostomy, colostomy, known fixed symptomatic stenosis or complex fistulae

- evidence of or treatment for C. difficile or other intestinal pathogen including
Cytomegalovirus within 28 days

- requiring or expected to require surgical intervention

- history or evidence of adenomatous colonic polyps not removed

- history of evidence of colonic dysplasia

- active substance abuse or psychiatric problems that may interfere with study

- chronic Hep B, C, or HIV infection

- pregnancy or planning to become pregnant

- upper CD

- history of adhesions preventing colonoscopy to cecum

- planned bowel resection within 3 mon of enrollment



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Crohn Disease
Intervention(s)
Biological: Placebo
Biological: Fecal Microbiota Transplant (FMT)
Primary Outcome(s)
Clinical and Endoscopic Remission [Time Frame: Week 8]
Secondary Outcome(s)
Quality of Life 2 [Time Frame: Week 8]
Clinical response [Time Frame: Week 8]
Endoscopic response [Time Frame: Week 8]
Quality of Life 1 [Time Frame: Week 8]
Clinical remission [Time Frame: Week 8]
Endoscopic remission [Time Frame: Week 8]
Quality of Life 3 [Time Frame: Week 8]
Secondary ID(s)
66218
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
University of Calgary
McMaster University
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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