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.
Subjects will be randomized in a 1:1 ratio to receive one of two diets that are thought to be beneficial for Crohn's disease for a period of 8 weeks. Initial evaluation will include a clinic visit with physical exam, medication review, supplemental documentation, and labs. Patients will be asked about their food allergies and intolerances against a master list of all ingredients used in both diets. Patients will then be provided with instructions on how to record their baseline dietary intake for two weeks prior to the intervention diet. At day 0 patients will begin their study diet. All study meals will be provided to the subject and an approved snack list for the randomized diet will be provided in a sealed envelope with their first week of meals. At the conclusion of intervention patients will be asked to resume their previous diet for 4 weeks and record their dietary intake. Stool and blood will be collected at baseline and at 4, 8, and 12 weeks. At the conclusion of the study patients will be told which diet they were on and will be provided with dietary consultation by a registered dietitian. Subjects who withdraw from the study before the 4 week assessment will be asked to provide a final stool sample at the time of withdrawal. If more than 2 subjects drop out prior to week 4, subject replacement will occur.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
University of Washington Medical Center
Seattle, Washington, United States
RECRUITINGFecal Calprotectin Remission
To compare the proportion of patients with calprotectin remission (fecal calprotectin level \< 250 and a decrease by ≥ 100 points) at 8 weeks post-dietary intervention for subjects on each diet
Time frame: 8 weeks
Fecal Calprotectin Response
Calprotectin response (decrease by ≥ 100 points) or calprotectin improvement (decrease by \> 50%) at weeks 4 and 8 for subjects on each diet. Comparison of the mean calprotectin between the 2 treatment groups.
Time frame: 8 weeks
Clinical Response
Proportion of patients on each diet with clinical response (HBI score decrease by ≥ 3) or remission (HBI score \< 5) at weeks 4 and 8
Time frame: 8 weeks
Metagenomics
To compare changes in the metagenomics of the fecal microbiome at 8 weeks relative to baseline for each diet
Time frame: 8 weeks
Microbiota correlation with clinical disease activity and inflammatory biomarkers
To determine if changes in the microbiota are associated with changes in clinical disease activity (HBI score), or inflammatory biomarkers (fecal calprotectin, C-reactive protein, etc.).
Time frame: 8 weeks
Future Use
To collect stool and blood for potential future analysis looking at proteomics and metabolomics.
Time frame: 8 weeks
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