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Food and Crohn's Exacerbation Study (FACES) (FACES)

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ClinicalTrials.gov Identifier: NCT01926730
Recruitment Status : Completed
First Posted : August 21, 2013
Last Update Posted : February 14, 2017
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Crohn's and Colitis Foundation
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment
Crohn's Disease Other: Restriction diet

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Food and Crohn's Exacerbation Study (FACES)
Actual Study Start Date : November 2013
Primary Completion Date : June 2016
Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Usual diet
Patients will follow a usual diet and consume at least 16 oz of water per day
Experimental: 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.
Other: Restriction diet
Selected food items will be limited in the participants diet

Primary Outcome Measures :
  1. Relapse of Crohn's Disease (CD) [ Time Frame: Every 8 weeks during the 48 week study period ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926730

United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Crohn's and Colitis Foundation
Principal Investigator: James D Lewis, MD, MSCE University of Pennsylvania

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01926730     History of Changes
Other Study ID Numbers: K24-DK078228-FACES
K24DK078228 ( U.S. NIH Grant/Contract )
First Posted: August 21, 2013    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases