Food and Crohn's Exacerbation Study (FACES)
Completed · Not applicable
Conditions studied: Crohn's Disease
In brief
The proposed study is a randomized controlled trial of a limited restriction diet compared to a regular diet among patients with Crohn's disease (CD) in remission. At baseline, patients will complete a semi-quantitative food frequency questionnaire assessing usual dietary patterns over the preceding month. Disease activity will be assessed with the abbreviated Crohn's Disease Activity Index (aCDAI)59. Self-reported disease status will be assessed during follow-up using an internet-based questionnaire. Repeat assessment of adherence to the study diets will be assessed with food frequency questionnaires (FFQs) administered after 20 weeks. Follow-up duration will be for 48 weeks. Statistical analysis will compare the time to relapse using Cox regression for patients in the two study arms. In the exploratory aim, we will compare outcomes among patients in the highest tertile for other food items and nutrients to those in the lowest tertile based on self-reported usual dietary patterns at baseline. Thus, the study population will be analyzed both as a randomized controlled trial and as a prospective cohort study.
Key facts
- Study ID
- NCT01926730
- Run by
- University of Pennsylvania
- People needed
- 216
- Starts
- 2013-11-01
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2017-02-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have an established diagnosis of CD.
- All patients must be in clinical remission at the time of entry into the study. Remission is defined as an aCDAI of less than 150.
You may not qualify if…
- Inflammatory bowel disease (IBD) unspecified / Indeterminate colitis
- Total or sub-total colectomy, ileostomy, or colostomy
- Unable to read and speak English
- No internet access
- Steroids other than budesonide ≤6mg/day with the prior two weeks
- Perianal fistula or abscess with more than scant drainage
- Age less than 18 years
- Pregnant or breastfeeding women
- Unwilling to follow the study diet
Where it is running
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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