Whole-Food, Plant-Based Diet for Active Crohn’s Disease
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-000714
NCT ID: NCT04982666
Sponsor Protocol Number: 21-000714
About this study
The overall objective of this proposal is to evaluate the potential therapeutic benefit of a whole-food, plant-based (WFPB) diet in patients with Crohn’s disease (CD). Our hypothesis is that patients adhering to WFPB diet will achieve higher rates of clinical remission and reduction in intestinal inflammation, as compared to controls who will implement FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols) diet. In order to further understand the pathogenesis by which diet may influence CD, we will also plan to study how WFPB may induce changes in the gut microbiota and intestinal permeability. We will test these hypotheses through the following specific aims, which will be conducted in CD patients only (excluding ulcerative colitis or indeterminate colitis), to standardize the underlying disorder.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 or MR enterography, based on discretion of reviewing radiologist; OR
- Documentation of active Crohn’s disease on colonoscopy, defined as SES-CD score (Simple Endoscopic Score for Crohn’s disease) 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.
Eligibility last updated 9/9/21. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Amanda Johnson, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available