Clinical trial NCT04982666: Whole-Food, Plant-Based Diet for Active Crohn's Disease
Official title: Assessing the Role of a Whole-Food, Plant-Based (WFPB) Diet in the Treatment of Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Crohn Disease
Keywords: inflammatory bowel disease
diet
crohn disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in symptomatic remission
timeFrame: Baseline, week 6, week 12
measure: Change in intestinal inflammation
timeFrame: Baseline, week 6, week 12
Secondary outcomes:
measure: Assess the ability of WFPB diet to improve rates of symptomatic response based on sCDAI
timeFrame: Will be evaluated at Visit 3 (week 6) and Visit 4 (week 12) for comparison to baseline.
measure: Measure the reduction of systemic inflammation based on hsCRP
timeFrame: Will obtain levels at Visit 3 (week 6) and Visit 4 (week 12), for comparison to baseline levels prior to dietary intervention.
measure: Assess rates of adherence to diet interventions
timeFrame: This will be administered at Visit 1 (to understand baseline), Visit 3 (week 6), and Visit 4 (week 12).
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Amanda M Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References: