Food and Crohn's Exacerbation Study (FACES)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Pennsylvania
Sponsor:
Collaborators:
Crohn's and Colitis Foundation of America
Information provided by (Responsible Party):
James Lewis, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01926730
First received: August 18, 2013
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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 Intervention
Crohn's Disease
Other: Restriction diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Food and Crohn's Exacerbation Study (FACES)

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Relapse of Crohn's Disease (CD) [ Time Frame: Every 8 weeks during the 48 week study period ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 612
Study Start Date: November 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01926730

Contacts
Contact: Erin D Gilroy, BS 215-746-4218 egilroy@mail.med.upenn.edu
Contact: Lisa C Nessel, MSS, MLSP 215-573-6003 nessel@mail.med.upenn.edu

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Crohn's and Colitis Foundation of America
Investigators
Principal Investigator: James D Lewis, MD, MSCE University of Pennsylvania
  More Information

No publications provided

Responsible Party: James Lewis, Professor of Medicine and Epidemiology, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01926730     History of Changes
Other Study ID Numbers: K24-DK078228-FACES, K24DK078228
Study First Received: August 18, 2013
Last Updated: July 10, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 28, 2014