A Culturally Tailored Dietary Intervention to Treat Crohn's Disease

Running, not enrolling · Not applicable

Conditions studied: Crohn Disease

In brief

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™.

Key facts

Study ID

NCT05627128

Run by

University of Massachusetts, Worcester

People needed

150

Starts

2022-09-06

Expected to finish

2026-11-30

Last updated by the study team

2026-04-17

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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

Where it is running

• University of Massachusetts Chan MedicaL School — Worcester, Massachusetts, United States
• University of Puerto Rico — San Juan, Puerto Rico, Puerto Rico

Full record on ClinicalTrials.gov

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