Status:
UNKNOWN
Can Intermittent Fasting Induce Weight Loss and Improve Gut Health as Compared to Standard Medical Care in Patients With Obesity/High BMI and Crohn's Disease.
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Crohn's and Colitis Foundation
Conditions:
Crohn Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Diet is a determinant of gut microbial diversity and composition and is recognized as a potential environmental trigger for IBD; for example, high-fat diets are associated with increased risk of CD in...
Detailed Description
Objectives: To determine if a 12-week IF intervention compared to SM: 1. Induces weight loss of at least 1 BMI unit. 2. Reduces intestinal and systemic inflammation. 3. Alters gut microbial community...
Eligibility Criteria
Inclusion
- ≥ 18 to ≤ 75 years of age;
- ileocolonic or colonic CD in clinical remission diagnosed through conventional definitions with a Harvey Bradshaw Index (HBI) \< 5 within 3 months of recruitment;
- presence of inflammation using an FCP ≥ 250 µg/g or a CRP ≥ 5 mg/L;
- stable dosing of biologic agents and/or immunomodulators and/or oral or rectal 5-ASA, and no changes to medical management (including corticosteroid exposure) for at least 3 months prior to recruitment
- presence of overweight or obesity with BMI \> 25 and a PG-SGA of class A.
Exclusion
- upper gastrointestinal involvement CD, fistulizing disease;
- documented strictures based on sonographic findings or colonoscopy within the last year;
- \> 1 small bowel resection;
- colectomy;
- presence of an ostomy;
- antibiotic use in past 3-months;
- pregnancy;
- corticosteroids in the last 3 months.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05230160
Start Date
March 1 2022
End Date
June 30 2025
Last Update
February 8 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
TRW building, Foothills, University of Calgary
Calgary, Alberta, Canada, T2N 4Z6