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.

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).

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.

Rheumatological diseases represent a widespread heterogeneous group of disorders, united by chronic musculoskeletal inflammatory processes. Despite the increasing effectiveness of new therapies, the lack of adequate treatments for certain conditions and the occurrence of adverse drug reactions have led to the need for alternative strategies, including food supplements. These products are perceived by the patient as a valuable aid without adverse effects. However, adverse reactions to food supplements have been reported, although their incidence cannot be established due to the lack of consumption data. In this context, the IntegraRE project aims at collecting information on the use of food supplements in rheumatology, considering both physicians and patients.

A survey-based cross-sectional study has been designed into two consecutive phases: Phase 1 aims to investigate rheumatologists’ knowledge, attitudes and recommendations to patients regarding food supplements, while Phase 2 focuses on estimating patients’ intake of food supplements, including the specific products used, unit consumed and reasons for their consumption. Questionnaires will be collected from at least 287 rheumatologists and 2000 patients, geographically distributed in proportion to the Italian population. These will gather information on sociodemographic variables, lifestyle factors, knowledge, clinical practices and supplement consumption.

The study protocol has been approved by the Ethics Committee of the Italian National Institute of Health (approval no. AOO 0032395 on 24 July 2024). The results, which will be widely disseminated through conference presentations, peer-reviewed publications and dedicated project webpage, will provide an understanding of the use of food supplements in rheumatology and allow guidelines to be drawn up on their correct use in the clinical practice of rheumatological diseases. Overall, this survey will increase people’s awareness of the effects of food supplements and encourage their safe and conscious use.