This trial is active, not recruiting.

Condition crohn's disease
Treatment restriction diet
Sponsor University of Pennsylvania
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date November 2013
End date December 2016
Trial size 612 participants
Trial identifier NCT01926730, K24-DK078228-FACES, K24DK078228


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(No Intervention)
Patients will follow a usual diet and consume at least 16 oz of water per day
Participants will follow a diet that limits intake of selected food items. Patients will consume at least 16 oz of water per day.
restriction diet
Selected food items will be limited in the participants diet

Primary Outcomes

Relapse of Crohn's Disease (CD)
time frame: Every 8 weeks during the 48 week study period

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Food and Crohn's Exacerbation Study (FACES)
Principal investigator James D Lewis, MD, MSCE
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Pennsylvania.