A Framework for Clinical Trials of Neurobiological Interventions That Target the Gut-Brain Axis in Inflammatory Bowel Disease

Inflamm Bowel Dis. 2021 Jul 9;izab153. doi: 10.1093/ibd/izab153. Online ahead of print.

Chung Sang Tse 1Siddharth Singh 1William J Sandborn 1


Author information

  • 1Division of Gastroenterology, University of California San Diego, San Diego, California, USA.


A growing body of evidence from preclinical, translational, and clinical studies supports a bidirectional relationship within the gut-brain axis that contributes to neurobiological symptoms including anxiety, depression, fatigue, stress, and sleep disturbance. These symptoms have a significant impact on health-related quality of life and functional ability in individuals with inflammatory bowel disease. Clinical studies that generate high-quality evidence on pharmacological and nonpharmacological (eg, psychosocial, behavioral) interventions are needed to ultimately improve access to safe and effective therapies that have a meaningful impact on patients and to guide medical and regulatory decisions. This review outlines a framework for designing and conducting randomized controlled trials for interventions that target neurobiological symptoms in patients with inflammatory bowel disease based on the most recent guidance published within the past 5 years from policy makers, clinicians specialized in inflammatory bowel disease, patient-reported outcomes methodologists, health economists, patient advocates, industry representatives, ethicists, and clinical trial experts.

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