Whole-Food, Plant-Based Diet for Active Crohn's Disease

Study Overview
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Brief Summary
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The purpose of this study is to assess the ability of a whole-food, plant-based (WFPB) diet to produce symptomatic remission in Crohn's Disease patients.

Detailed Description
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The goal of this proposal is to evaluate the efficacy of a whole-food, plant-based (WFPB) diet in the treatment of active Crohn's Disease (CD). Epidemiologic studies suggest that environmental factors, including diet, likely play a role in the pathogenesis and disease course of Inflammatory Bowel Disease (IBD). Evidence also exists to support the idea that dietary practices, such as adherence to a plant-based as opposed to a more western diet, can significantly modify the microbiome composition and intestinal barrier function - both of which likely impact the disease course of IBD. The overall hypothesis is that adoption of a WFPB diet will reduce both symptoms and intestinal inflammation in CD patients, as well as increase microbial diversity. Patients will be randomized to receive education on and adopt either WFPB or FODMAP diet, which will be adhered to for a total of 12 weeks. Two primary outcomes which will be assessed are rates of clinical remission based on sCDAI and also reduction in intestinal inflammatory burden based on fecal calprotectin. Several secondary outcomes will also be reviewed to include assessment for alterations in the gut microbiome and intestinal permeability, rates of clinical response based on sCDAI, changes in systemic inflammation based on CRP, and adherence rates to the diet interventions.

Official Title
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Assessing the Role of a Whole-Food, Plant-Based (WFPB) Diet in the Treatment of Active Crohn's Disease

Conditions
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Crohn Disease

Intervention / Treatment
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* Other: Whole-Food, Plant-Based Diet
* Other: FODMAP Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older. Have the capacity for informed consent. Subjects must carry a diagnosis of CD at time of enrollment; the CD diagnosis will be based on clinical impression and documentation of the treating physician. Have active symptoms based on sCDAI score of > 175. Have active inflammation documented by either: a fecal calprotectin of >150 µg/g; OR high sensitivity C-reactive protein (hs-CRP) >5 mg/L; OR evidence of active inflammation on CT (Computer Tomography) or MR (Magnetic Resonance) enterography, based on discretion of reviewing radiologist; OR documentation of active Crohn's disease on colonoscopy, defined as SES-CD (Simple Endoscopic Score for Crohn's disease) score of 3 or greater. Patients may continue their currently prescribed, stable doses of medical therapy during the study duration. Ability to have no more than 2 drinks/day for men and 1 drink/day for women. Ability and willingness to adhere to one of the study diets. Exclusion Criteria: Hospitalized patients. Disease activity score sCDAI > 400 Already following plant-based diet, FODMAP diet, or other nutritional trials. Have recent changes in medical therapy (no start or change in immunomodulator, natalizumab, or vedolizumab within 12 weeks; 5-ASA, anti-TNFα agent, ustekinumab, or tofacitinib within 8 weeks; or corticosteroids within 2 weeks of randomization). Have an ostomy or ileoanal pouch. Have known luminal stricture or stenosis that would preclude consumption of fresh fruits and vegetables. Plans for GI surgery within six weeks of enrollment. Pregnant, planning to become pregnant, or breastfeeding. Have other conditions such as diabetes or celiac disease that may impact ability to follow study diet.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whole-Food, Plant-Based Diet Group<br>Subjects with a known diagnosis of Crohn's disease will follow a whole-food, plant-based diet for a total of 12 weeks | Other: Whole-Food, Plant-Based Diet<br>* This diet is focused on nutritional needs with natural, minimally-processed plant foods.<br>|
| Active Comparator: FODMAP Diet<br>Subjects with a known diagnosis of Crohn's disease will follow a FODMAP diet for a total of 12 weeks | Other: FODMAP Diet<br>* An elimination diet of fermentable, oligosaccharides, disaccharides, monosaccharides and polyols<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in symptomatic remission | Assessed utilizing the short Crohn's Disease Activity Index (sCDAI) | Baseline, week 6, week 12 | 
| Change in intestinal inflammation | Assessed by fecal calprotectin levels. Elevated baseline levels of fecal calprotectin will be defined as >150 µg | Baseline, week 6, week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the ability of WFPB diet to improve rates of symptomatic response based on sCDAI | Clinical response will be assessed based on changes in sCDAI, with response defined as reduction in sCDAI ≥ 100 as compared to baseline. | Will be evaluated at Visit 3 (week 6) and Visit 4 (week 12) for comparison to baseline. | 
| Measure the reduction of systemic inflammation based on hsCRP | Will be evaluated by comparing changes in high-sensitivity C-reactive protein (hsCRP), with reduction in systemic inflammation defined as normalization in hs-CRP to <5 mg/L. | Will obtain levels at Visit 3 (week 6) and Visit 4 (week 12), for comparison to baseline levels prior to dietary intervention. | 
| Assess rates of adherence to diet interventions | Will assess rates of adherence by utilizing Viocare food frequency questionnaire. | This will be administered at Visit 1 (to understand baseline), Visit 3 (week 6), and Visit 4 (week 12). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inflammatory bowel disease, diet, crohn disease