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Recruiting
NCT05627128
A Culturally Tailored Dietary Intervention to Treat Crohn's Disease
Conditions: Crohn Disease
Sex: All
Ages: 21 Years – 65 Years
Phase: NA
Enrollment: 150
Sponsor: University of Massachusetts, Worcester
Location: United States
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™.
Eligibility Criteria
Inclusion Criteria:21 to 65 years oldConfirmed Crohn's disease diagnosis is with mild to moderate Crohn's disease symptoms (sCDAI>220 <450)Stable doses of medications are screened; thiopurines, natalizumab, vedolizumab, methotrexate (12 weeks), anti-tumor necrosis factor (TNF), ustekinumab (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 studyExclusion Criteria:OstomyUse of Specific Carbohydrate Diet of IBD-AID™ within 4 weeks of screeningUse of prescribed probiotics within 4 weeks of screening> 20mg prednisone or equivalentRecent C. difficile colitis
Source: ClinicalTrials.gov (NCT05627128). StuddyBuddy aggregates publicly available trial information.