Inflammatory bowel diseases (IBDs): a cross-sectional analysis of the psychological and biological mechanisms underlying intestinal and extra-intestinal symptoms-GastroPsy study protocol.

INTRODUCTION

Inflammatory bowel diseases (IBDs) are chronic conditions characterised by intestinal and systemic inflammation, often associated with significant psychological distress. Emerging evidence highlights a bidirectional relationship between inflammation and psychological factors, mediated by the gut-brain axis. Psychological distress may not only result from chronic inflammation but also contribute to symptom persistence and disease exacerbation. Despite this, clinical management of IBD primarily focuses on controlling inflammation, often overlooking psychological factors that may influence disease activity and treatment response.

METHOD AND ANALYSIS: GastroPsy protocol will last for 24 months and will follow a cross-sectional design. At least 150 participants will undergo a clinical evaluation based on the detection of biological, medical and psychological indicators and variables. The evaluation battery will comprise seven validated questionnaires. Through a k-means cluster analysis, the study aims to derive and describe data-driven clusters of IBD patients, finally exploring associations between identified clusters and external clinical variables (e.g. clinical activity).

ETHICS AND DISSEMINATION: Ethical Committee Approval was obtained from the CEtRA Abruzzo Region (IT) (Protocol ID 228/2025). The results of the present project will be published in peer-reviewed journals, disseminated electronically and in print, and presented as abstracts and/or personal communications during national and international conferences.