Food and Crohn's Exacerbation Study (FACES)

NCT01926730 | Completed

• 2 other identifiers: K24-DK078228-FACESK24DK078228
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Usual diet

NO INTERVENTION

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

Restriction diet

EXPERIMENTAL

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

Interventions

Restriction diet OTHER

Selected food items will be limited in the participants diet

Restriction diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Crohn's and Colitis Foundation: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• James D Lewis, MD, MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2013
• First Posted: August 21, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 14, 2017

Record last verified: 2017-02

Locations

US (1)