Food and Crohn's Exacerbation Study (FACES) (FACES)
Primary Purpose
Crohn's Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Restriction diet
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease
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
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual diet
Restriction diet
Arm Description
Patients will follow a usual diet and consume at least 16 oz of water per day
Participants will follow a diet that limits intake of selected food items. Patients will consume at least 16 oz of water per day.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01926730
First Posted
August 18, 2013
Last Updated
February 13, 2017
Sponsor
University of Pennsylvania
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Crohn's and Colitis Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01926730
Brief Title
Food and Crohn's Exacerbation Study (FACES)
Acronym
FACES
Official Title
Food and Crohn's Exacerbation Study (FACES)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Crohn's and Colitis Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual diet
Arm Type
No Intervention
Arm Description
Patients will follow a usual diet and consume at least 16 oz of water per day
Arm Title
Restriction diet
Arm Type
Experimental
Arm Description
Participants will follow a diet that limits intake of selected food items. Patients will consume at least 16 oz of water per day.
Intervention Type
Other
Intervention Name(s)
Restriction diet
Intervention Description
Selected food items will be limited in the participants diet
Primary Outcome Measure Information:
Title
Relapse of Crohn's Disease (CD)
Description
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.
Time Frame
Every 8 weeks during the 48 week study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James D Lewis, MD, MSCE
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Food and Crohn's Exacerbation Study (FACES)
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