Diet as Essential Therapy (DIET) for Inflammatory Bowel Disease
Status unconfirmed · Not applicable
Conditions studied: Crohn Disease
In brief
Recent data suggest that diet in inflammatory bowel disease (IBD) may lead to both symptom control and disease remission. Historically certain diets have been recommended for patients with Crohn's disease during exacerbations despite lack of data supporting efficacy. The investigators propose to evaluate two such diets by randomizing 32 subjects with mildly to moderately active Crohn's disease to one of two diets that differ in the amount and type of carbohydrates and fiber. Subjects will remain on the diet for 8 weeks and will be evaluated for changes from baseline in inflammatory biomarkers, symptomatic disease activity, and the microbiome.
Key facts
- Study ID
- NCT03012542
- Run by
- University of Washington
- People needed
- 32
- Starts
- 2017-01-01
- Expected to finish
- 2019-12-01
- Last updated by the study team
- 2018-05-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Consentable adults of age 18 or older.
- Diagnosis of Crohn's disease made by a primary gastroenterologist based upon history, physical exam, laboratory/radiological studies, and endoscopy with biopsy.
- Fecal Calprotectin ≥ 300
- Mild to moderate disease activity based upon a modified Harvey Bradshaw Index score of 5-16.
- On stable medication doses for ≥ 2 months.
You may not qualify if…
- Inability/unwillingness to adhere to dietary recommendations.
- Allergy or intolerance to any major component of the diets. Major component defined as an ingredient which, when left out of intervention diets, may affect study outcomes.
- Allium intolerance
- Exclusively vegetarian diet
- Active intra-abdominal or perianal abscess/fistula
- Symptomatic bowel stricture
- Other serious medical conditions such as neurological, liver, kidney, autoimmune, or systemic disease
- Use of corticosteroids within 1 month prior to baseline visit
- Tobacco, alcohol, or illicit drug abuse
- Pregnant subjects
- Celiac disease
- Patients already on one of the diets being studied
- C. difficile or other enteric infection (O\&P, stool enterics)
- Antibiotic use within 2 months prior to baseline visit
Where it is running
- University of Washington Medical Center — Seattle, Washington, United States (enrolling)
Full record on ClinicalTrials.gov
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