Food and Crohn's Exacerbation Study (FACES) (FACES)
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| ClinicalTrials.gov Identifier: NCT01926730 |
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Recruitment Status :
Completed
First Posted : August 21, 2013
Last Update Posted : February 14, 2017
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Sponsor:
University of Pennsylvania
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Crohn's and Colitis Foundation
Information provided by (Responsible Party):
University of Pennsylvania
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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 | Phase |
|---|---|---|
| Crohn's Disease | Other: Restriction diet | Not Applicable |
| 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 |
| Actual Primary Completion Date : | June 2016 |
| Actual Study Completion Date : | June 2016 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Crohn disease
MedlinePlus related topics:
Crohn's Disease
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Usual diet
Patients will follow a usual diet and consume at least 16 oz of water per day
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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.
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Other: Restriction diet
Selected food items will be limited in the participants diet |
Primary Outcome Measures :
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
Locations
| 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
Investigators
| Principal Investigator: | James D Lewis, MD, MSCE | University of Pennsylvania |
| Responsible Party: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01926730 |
| 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:
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Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |