Clinical trial NCT05627128: A Culturally Tailored Dietary Intervention to Treat Crohn's Disease
Official title: Anti-Inflammatory Diet (Dieta Antiinflamatoria or DAIN in Spanish): a Crohn's Disease Management Strategy Tailored for Puerto Ricans
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Crohn Disease
Keywords: diet
inflammation
microbiome
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: University of Puerto Rico
name: The Leona M. and Harry B. Helmsley Charitable Trust
First posted: 2022-11-25
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized intervention trial in adults with Crohn's disease.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Improvement of health-related quality of life
timeFrame: Week 0, 6, 10, 14
Secondary outcomes:
measure: Change of Inflammation
timeFrame: Week 0, 6, 10, 14
measure: Gut Microbiome changes
timeFrame: Week 0, 6, 10, 14
measure: Dietary compliance
timeFrame: Week 0, 6, 10, 14
measure: Clinical response and remission
timeFrame: Week 0, 6, 10, 14
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Chan MedicaL School
state: Massachusetts
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico
Study officials:
affiliation: University of Massachusetts Chan Medical School
name: Ana L Maldonado-Contreras, PhD
role: PRINCIPAL_INVESTIGATOR
References: