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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04982666
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Mayo Clinic
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Amanda M Johnson, MD
Principal Investigator Affiliation Mayo Clinic
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

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

Active Comparator: FODMAP Diet

Subjects with a known diagnosis of Crohn's disease will follow a FODMAP diet for a total of 12 weeks

Interventions

Other: - Whole-Food, Plant-Based Diet

This diet is focused on nutritional needs with natural, minimally-processed plant foods.

Other: - FODMAP Diet

An elimination diet of fermentable, oligosaccharides, disaccharides, monosaccharides and polyols

Contact a Trial Team

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Mayo Clinic in Rochester, Rochester, Minnesota

Status

Address

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

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