Food and Crohn's Exacerbation Study (FACES)

NCT ID: NCT01926730

Last Updated: 2017-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-06-30

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.

Conditions

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual diet

Patients will follow a usual diet and consume at least 16 oz of water per day

Group Type: NO_INTERVENTION

No interventions assigned to this group

Restriction diet

Participants will follow a diet that limits intake of selected food items. Patients will consume at least 16 oz of water per day.

Group Type: EXPERIMENTAL

Restriction diet

Intervention Type: OTHER

Selected food items will be limited in the participants diet

Interventions

Restriction diet

Selected food items will be limited in the participants diet

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Crohn's and Colitis Foundation

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James D Lewis, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

K24DK078228

Identifier Type: NIH

Identifier Source: secondary_id

View Link

K24-DK078228-FACES

Identifier Type: -

Identifier Source: org_study_id