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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Crohn Disease
• Intervention / Treatment: Other: Whole-Food, Plant-Based Diet; Other: FODMAP Diet

Detailed Description

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Whole-Food, Plant-Based Diet Group; 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; This diet is focused on nutritional needs with natural, minimally-processed plant foods.
ACTIVE_COMPARATOR: FODMAP Diet; Subjects with a known diagnosis of Crohn's disease will follow a FODMAP diet for a total of 12 weeks	Other: FODMAP Diet; An elimination diet of fermentable, oligosaccharides, disaccharides, monosaccharides and polyols

What is the study measuring?

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).

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2022
• Primary Completion (ANTICIPATED): June 1, 2022
• Study Completion (ANTICIPATED): October 1, 2022

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (ACTUAL): July 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: diet; inflammatory bowel disease; crohn disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 21-000714

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No