April 24, 2026 · Gastroenterology · DOI: 10.1053/j.gastro.2025.12.040

Design of Treatment Trials for Disorders of Gut-Brain Interaction

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The authors aim to address the challenges and methodologies involved in designing treatment trials for disorders of gut-brain interaction (DGBI), particularly given the predominance of research focused on irritable bowel syndrome in adults. They discuss the evolution of trial designs, including the incorporation of dietary and behavioral therapies, and emphasize the importance of validated patient-reported outcomes and adherence to clinical standards to improve treatment strategies for these complex disorders. The article serves as a comprehensive guide on best practices for conducting and reporting DGBI treatment trials.

Gregory S Sayuk, Darren M Brenner, Florencia Carbone, Simon R Knowles, Brian E Lacy, Heidi M Staudacher, Alexander C Ford

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