Food and Crohn's Exacerbation Study (FACES)

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Food and Crohn's Exacerbation Study (FACES)

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Other: Restriction diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual diet<br>Patients will follow a usual diet and consume at least 16 oz of water per day | |
| Experimental: Restriction diet<br>Participants will follow a diet that limits intake of selected food items. Patients will consume at least 16 oz of water per day. | Other: Restriction diet<br>* Selected food items will be limited in the participants diet<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse of Crohn's Disease (CD) | Relapse of CD is defined as an increase in the aCDAI by >=60 points and to >150. Additionally, undergoing CD surgery or starting any new CD medication (steroids, mesalamine, azathioprine, methotrexate, anti-Tumor Necrosis Factor α (anti-TNF), anti-α4) for the treatment of CD symptoms during the interval between two visits will be considered to have identified a clinical relapse. | Every 8 weeks during the 48 week study period |