A Culturally Tailored Dietary Intervention to Treat Crohn's Disease

NCT05627128 | Active Not Recruiting DMC

• 2 other identifiers: 1250122R-2102-05006
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 2

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™.

Conditions

Crohn Disease

Keywords

diet; inflammation; microbiome

Outcome Measures

Primary Outcomes (1)

• Improvement of health-related quality of life

  Improvement of health-related quality of life (increase of the short Inflammatory Bowel Disease Questionnaire score (SIBDQ)). The SIBDQ scores range between 10 and 70 points. A slightly impaired quality of life is indicated by scores from 60 to 70 points, moderately impaired quality of life from 45 to 60 points, and severely impaired quality of life from 10 to 45 points.

  Week 0, 6, 10, 14

Secondary Outcomes (4)

• Change of Inflammation

  Week 0, 6, 10, 14

• Gut Microbiome changes

  Week 0, 6, 10, 14

• Dietary compliance

  Week 0, 6, 10, 14

• Clinical response and remission

  Week 0, 6, 10, 14

Study Arms (2)

Arm1: Crohn's disease patients + DAIN

EXPERIMENTAL

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

Other: DAIN

Arm 2: Crohn's disease patients no intervention

NO INTERVENTION

Participants will continue consuming their usual diet, with no intervention

Interventions

DAIN 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.

Arm1: Crohn's disease patients + DAIN

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator
• University of Massachusetts, Worcester: lead
• University of Puerto Rico: collaborator

Study Sites (2)

University of Massachusetts Chan MedicaL School

Worcester, Massachusetts, 01605, United States

Location

University of Puerto Rico

San Juan, Puerto Rico, 00935, Puerto Rico

Location

MeSH Terms

Conditions

Crohn Disease; Inflammation

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ana L Maldonado-Contreras, PhD

  University of Massachusetts Chan Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All staff collecting data (e.g., dietary assessment) or assaying samples (e.g., fecal calprotectin, cytokines, sequencing) including the PI's, will be blinded to diet group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant Professor

Model Details: Randomized intervention trial in adults with Crohn's disease.

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: November 25, 2022
• Study Start: September 6, 2022
• Primary Completion: May 31, 2025
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: 2 years
• Access Criteria: Access to databases and associated software tools generated under the project will be available for educational, research and non-profit purposes. A portal will be created on the study website whereby anyone interested in collaborating or accessing to the data may submit a request form. Publication of data shall occur during the project, if appropriate, or at the end of the project, consistent with normal scientific practices. Research data, which documents, supports and validates research findings will be made available after the main findings from the final research data set have been accepted for publication. Such research data will be redacted to prevent the disclosure of personal identifiers.

Locations

PR (1); US (1)