Food and Crohn's Exacerbation Study (FACES)
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/15/2017 |
| Start Date: | November 2013 |
| End Date: | June 2016 |
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.
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.
Inclusion Criteria:
1. Patients must have an established diagnosis of CD.
2. 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.
Exclusion Criteria:
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
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