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

Primary Purpose

Crohn Disease

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Whole-Food, Plant-Based Diet

FODMAP Diet

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring inflammatory bowel disease, diet, crohn disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Whole-Food, Plant-Based Diet Group

FODMAP Diet

Arm Description

Subjects with a known diagnosis of Crohn's disease will follow a whole-food, plant-based diet for a total of 12 weeks

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

Outcomes

Primary Outcome Measures

Change in symptomatic remission

Assessed utilizing the short Crohn's Disease Activity Index (sCDAI)

Change in intestinal inflammation

Assessed by fecal calprotectin levels. Elevated baseline levels of fecal calprotectin will be defined as >150 µg

Secondary Outcome Measures

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

Clinical response will be assessed based on changes in sCDAI, with response defined as reduction in sCDAI ≥ 100 as compared to baseline.

Measure the reduction of systemic inflammation based on hsCRP

Will be evaluated by comparing changes in high-sensitivity C-reactive protein (hsCRP), with reduction in systemic inflammation defined as normalization in hs-CRP to <5 mg/L.

Assess rates of adherence to diet interventions

Will assess rates of adherence by utilizing Viocare food frequency questionnaire.

Full Information

NCT ID

NCT04982666

First Posted

June 3, 2021

Last Updated

May 20, 2022

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT04982666

Brief Title

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

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Difficulties with recruitment and unable to enroll any subjects

Study Start Date

April 2022 (Anticipated)

Primary Completion Date

June 2022 (Anticipated)

Study Completion Date

October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn Disease

Keywords

inflammatory bowel disease, diet, crohn disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Whole-Food, Plant-Based Diet Group

Arm Type

Experimental

Arm Description

Subjects with a known diagnosis of Crohn's disease will follow a whole-food, plant-based diet for a total of 12 weeks

Arm Title

FODMAP Diet

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Whole-Food, Plant-Based Diet

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

FODMAP Diet

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in symptomatic remission

Description

Assessed utilizing the short Crohn's Disease Activity Index (sCDAI)

Time Frame

Baseline, week 6, week 12

Title

Change in intestinal inflammation

Description

Assessed by fecal calprotectin levels. Elevated baseline levels of fecal calprotectin will be defined as >150 µg

Time Frame

Baseline, week 6, week 12

Secondary Outcome Measure Information:

Title

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

Description

Clinical response will be assessed based on changes in sCDAI, with response defined as reduction in sCDAI ≥ 100 as compared to baseline.

Time Frame

Will be evaluated at Visit 3 (week 6) and Visit 4 (week 12) for comparison to baseline.

Title

Measure the reduction of systemic inflammation based on hsCRP

Description

Will be evaluated by comparing changes in high-sensitivity C-reactive protein (hsCRP), with reduction in systemic inflammation defined as normalization in hs-CRP to <5 mg/L.

Time Frame

Will obtain levels at Visit 3 (week 6) and Visit 4 (week 12), for comparison to baseline levels prior to dietary intervention.

Title

Assess rates of adherence to diet interventions

Description

Will assess rates of adherence by utilizing Viocare food frequency questionnaire.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amanda M Johnson, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

12. IPD Sharing Statement

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

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

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