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

NCT04982666 | Withdrawn

• 1 other identifier: 21-000714
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Crohn Disease

Keywords

inflammatory bowel disease; diet; crohn disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Assess the ability of WFPB diet to improve rates of symptomatic response based on sCDAI

  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 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

  This will be administered at Visit 1 (to understand baseline), Visit 3 (week 6), and Visit 4 (week 12).

Study Arms (2)

Whole-Food, Plant-Based Diet Group

EXPERIMENTAL

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

FODMAP Diet

ACTIVE COMPARATOR

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

Other: FODMAP Diet

Interventions

Whole-Food, Plant-Based Diet OTHER

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

Whole-Food, Plant-Based Diet Group

FODMAP Diet OTHER

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

FODMAP Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Interventions

Diet, Plant-Based; FODMAP Diet

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Elimination Diets

Study Officials

• Amanda M Johnson, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: July 29, 2021
• Study Start: April 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: October 1, 2022
• Last Updated: May 26, 2022

Record last verified: 2022-05