A Culturally Tailored Dietary Intervention to Treat Crohn's Disease

Crohn Disease Clinical Trial

— DAIN  

Official title:

Anti-Inflammatory Diet (Dieta Antiinflamatoria or DAIN in Spanish): a Crohn's Disease Management Strategy Tailored for Puerto Ricans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05627128
• Other study ID #: 1250122
• Secondary ID: R-2102-05006
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2022
• Est. completion date: October 30, 2025

Study information

• Verified date: June 2023
• Source: University of Massachusetts, Worcester
• Contact: Ana L Maldonado-Contreras, PhD
• Phone: 774-455-3796
• Email: ana.maldonado[@]umassmed.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of the study is to test the efficacy of a dietary intervention in inducing clinical response and remission for patients with Crohn's disease in a randomized controlled trial. The intervention diet: DAIN has been adapted from the Inflammatory Bowel Disease Anti-Inflammatory Diet or IBD-AID™ taking into account the food availability and preferences of Puerto Ricans. DAIN also includes traditional foods commonly consumed in the typical Puerto Rican diet while maintaining the fundamental components of the IBD-AID™.

Description:

Crohn's disease is a chronic recurrent inflammatory disorder of the gastrointestinal that results from an inappropriate inflammatory response to an altered gut microbiome (i.e., dysbiosis). Diet is the main driver of microbiome composition. Diet also has been increasingly recognized as a cost-effective strategy to induce remission in pediatric and adult patients with Crohn's disease but diets that can substitute traditional and locally available foods among Puerto Ricans have not been explored. DAIN, a newly created dietary program, incorporates an extensive patient curriculum of recipes and menus adapted to the local availability and food preferences of Puerto Rican patients with Crohn's disease. This study aims to address three questions: whether DAIN a diet adapted to Puerto Rican patients with Crohn's disease, can: 1) induce clinical response and remission; 2) change the inflammatory tone, and 3) revert dysbiosis in Crohn's disease patients.

Participants will be randomized 1:1 ratio into two arms:

• Arm 1 Crohn's disease patients + DAIN (Experimental): this group of patients will participate in ten weeks of DAIN intervention (From week 1 to week 10)

• Arm 2 Crohn's disease patients no intervention (Control): this group of patients will not participate in the DAIN dietary intervention and will continue the usual diet.

Participation in the study lasts for 15 weeks with four-time points: week 0 (baseline), week 6, week 10, and week 14. At each time point, all subjects will complete a series of questionnaires to assess overall health, Crohn's disease activity, and dietary compliance. Blood and stool samples will be also collected at home at each time point. Samples will be either shipped or brought to the Research Unit at the Inflammatory Bowel Disease Clinic at the University of Puerto Rico.

The primary outcome is clinical response and remission. Secondary outcomes are: (i) reduction of inflammation, (ii) changes in the gut microbiome, and (iii) dietary compliance.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 30, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• 21 to 65 years old

• Confirmed Crohn's disease diagnosis is with mild to moderate Crohn's disease symptoms (sCDAI>220 <450)

• Stable doses of medications are screened; thiopurines, natalizumab, vedolizumab, methotrexate (12 weeks), anti-tumor necrosis factor (TNF), ustekinumab (8 weeks), 5-aminosalicylic acid (5-ASA) (2 weeks), steroids (1 week)

• Willingness and capacity to significantly change diet (arm 1)

• Willing and able to comply with specimen collection and other study procedures, and to complete the study

Exclusion Criteria:

• Ostomy

• Use of Specific Carbohydrate Diet of IBD-AID™ within 4 weeks of screening

• Use of prescribed probiotics within 4 weeks of screening

• > 20mg prednisone or equivalent

• Recent C. difficile colitis

• Pregnancy

• Presence of symptomatic or significant structure or history of obstruction in the past 6 months

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Other:
• DAIN
Participants in the experimental arm will have access to the newly created DAIN curriculum including menus, recipes, and recorded 'how to' recipes. Participants in the experimental arm will also have once-per-week dietary counseling with DAIN-trained nutritionists and monthly cooking classes with a DAIN-trained chef.

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico	San Juan
United States	University of Massachusetts Chan MedicaL School	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	The Leona M. and Harry B. Helmsley Charitable Trust, University of Puerto Rico

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response and remission	Clinical response and remission will be assessed by the Short Crohn's Disease Activity Index (sCDAI) surveyed at each time point. sCDAI scores range from 0 (no active disease) to 600 points (severe disease). An sCDAI reduction of 70 points will be considered clinical response and an sCDAI < 150 points will be considered remission.	Week 0, 6, 10, 14
Secondary	Change of Inflammation	Changes in inflammation will be determined by levels of calprotectin in stools and C-reactive protein (CRP) in the blood. Both stool and blood will be collected at each time point. Decreased levels of fecal calprotectin and CRP indicate a decrease in inflammation and vice versa.	Week 0, 6, 10, 14
Secondary	Gut Microbiome changes	Gut microbiome changes related to the dietary intervention will be assessed by metagenomic shotgun sequencing of stool samples collected at each time point.	Week 0, 6, 10, 14
Secondary	Dietary compliance	DAIN Dietary compliance will be evaluated by calculating the Healthy Eating Index (HEI) score from the assessment tools: 24-Hour Dietary Recalls (24HDRs) and Food Frequency Questionnaires, surveyed at each time point. The HEI is composed of 13 diet components: total fruits, whole fruits, total vegetables, greens and beans, dairy, total protein foods, seafood and plant proteins, fatty acids, refined grains, whole grains, sodium, added sugars, and saturated fats. A minimum number of servings per component have been established, and the scoring of the HEI components is based on these established values. The total maximum score is equal to 100. Higher values represent closer compliance with DAIN.	Week 0, 6, 10, 14