A Culturally Tailored Dietary Intervention to Treat Crohn's Disease

NCT ID: NCT05627128

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-06
• Study Completion Date: 2025-11-30

Brief 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™.

Detailed 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 Improvement of health-related quality of life. Secondary outcomes are: (i) reduction of inflammation, (ii) changes in the gut microbiome, (iii) clinical response and remission,and (iii) dietary compliance.

Conditions

Crohn Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm1: Crohn's disease patients + DAIN

Participants will have 10 weeks of DAIN intervention (From week 1 to week 10)

Group Type: EXPERIMENTAL

DAIN

Intervention Type: OTHER

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.

Arm 2: Crohn's disease patients no intervention

Participants will continue consuming their usual diet, with no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 21 to 65 years old
• Confirmed CD diagnosis with sCDAI <450 (includes values ranging from remission, mild to moderate activity)
• Moderate to severe impaired QoL (sIBDQ<60)
• Stable doses of medications are screened; thiopurines, natalizumab, methotrexate (12 weeks), anti-tumor necrosis factor (TNF), ustekinumab, vedolizumab (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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Puerto Rico

OTHER

Sponsor Role: collaborator

The Leona M. and Harry B. Helmsley Charitable Trust

OTHER

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Ana Maldonado-Contreras

Assitant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana L Maldonado-Contreras, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts Chan Medical School

Locations

University of Massachusetts Chan MedicaL School

Worcester, Massachusetts, United States

University of Puerto Rico

San Juan, Puerto Rico, Puerto Rico

Countries

United States; Puerto Rico

Other Identifiers

R-2102-05006

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1250122

Identifier Type: -

Identifier Source: org_study_id