NCT05627128Active, not recruiting
A Culturally Tailored Dietary Intervention to Treat Crohn's Disease
Anti-Inflammatory Diet (Dieta Antiinflamatoria or DAIN in Spanish): a Crohn's Disease Management Strategy Tailored for Puerto Ricans
Source: ClinicalTrials.gov · Last updated 17 Apr 2026
Brief summary (registry, in English)
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™.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 11 Oct 2022
- Start date
- 6 Sept 2022
- Primary completion date
- 31 May 2025
- Lead sponsor
- University of Massachusetts, Worcester
- Diseases
- Crohn's disease
- NCT number
- NCT05627128
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 6 Sept 2022 to the primary completion date, 31 May 2025
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Presence of symptomatic or significant structure or history of obstruction in the past 6 months
Other
- 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
Who the study is looking for
- 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
Age in the registry: 21 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Puerto Rico Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| University of Massachusetts Chan Medical School Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.