Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years and Over|
- - 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.
- - 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.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
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|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Study Website:||View Trial Website|
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.
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
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
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.