Crohn DiseaseNCT04982666
Whole-Food, Plant-Based Diet for Active Crohn's Disease
A study testing Whole-Food, Plant-Based Diet and FODMAP Diet in people with Crohn Disease, run by Mayo Clinic.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Whole-Food, Plant-Based Diet and FODMAP Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: Assessing the Role of a Whole-Food, Plant-Based (WFPB) Diet in the Treatment of Active Crohn's Disease
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.
Read the 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.
- Conditions
- Crohn Disease
- Being tested
- Whole-Food, Plant-Based Diet, FODMAP Diet
- Keywords
- inflammatory bowel disease, diet, crohn disease
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-Food, Plant-Based DietOther
This diet is focused on nutritional needs with natural, minimally-processed plant foods.
FODMAP DietOther
An elimination diet of fermentable, oligosaccharides, disaccharides, monosaccharides and polyols
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: FODMAP Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptomatic remission
Assessed utilizing the short Crohn's Disease Activity Index (sCDAI)
Measured: 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
Measured: Baseline, week 6, week 12
Secondary outcomes (3)
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.
Measured: 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 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.
Measured: 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
Will assess rates of adherence by utilizing Viocare food frequency questionnaire.
Measured: This will be administered at Visit 1 (to understand baseline), Visit 3 (week 6), and Visit 4 (week 12).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study startApr 2022 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionOct 2022 (estimated)
Why it stopped: Difficulties with recruitment and unable to enroll any subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda M. Johnson, Mayo Clinic
- Investigators
- Amanda M Johnson, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982666
- Sponsor's protocol ID
- 21-000714
- Status last verified
- May 2022
- First submitted
- 3 Jun 2021
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Role of a Whole-Food, Plant-Based (WFPB) Diet in the Treatment of Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT04982666
- Acronym / sponsor ID
- 21-000714
- Conditions
- Crohn Disease
- Keywords
- inflammatory bowel disease, diet, crohn disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulties with recruitment and unable to enroll any subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 29 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole-Food, Plant-Based Diet Group | Experimental | Other: Whole-Food, Plant-Based DietSubjects with a known diagnosis of Crohn's disease will follow a whole-food, plant-based diet for a total of 12 weeks |
| FODMAP Diet | Active comparator | Other: FODMAP DietSubjects with a known diagnosis of Crohn's disease will follow a FODMAP diet for a total of 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole-Food, Plant-Based DietThis diet is focused on nutritional needs with natural, minimally-processed plant foods. | Other | Whole-Food, Plant-Based Diet Group |
| FODMAP DietAn elimination diet of fermentable, oligosaccharides, disaccharides, monosaccharides and polyols | Other | FODMAP Diet |
Primary outcome
Change in symptomatic remission
Time frame: Baseline, week 6, week 12
Assessed utilizing the short Crohn's Disease Activity Index (sCDAI)
Change in intestinal inflammation
Time frame: Baseline, week 6, week 12
Assessed by fecal calprotectin levels. Elevated baseline levels of fecal calprotectin will be defined as >150 µg
3 secondary outcomes
Assess the ability of WFPB diet to improve rates of symptomatic response based on sCDAI
Time frame: 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
Time frame: 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
Time frame: This will be administered at Visit 1 (to understand baseline), Visit 3 (week 6), and Visit 4 (week 12).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda M Johnson, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Whole-Food, Plant-Based Diet and FODMAP Diet in people with Crohn Disease, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in symptomatic remission (time frame: Baseline, week 6, week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.