Characteristics and Outcomes of Outpatients Referred to a Gut Microbiota Clinic

What this Trial Is About

Researchers are investigating the role of gut microbiota in human health, focusing on its influence on metabolism, immunity, and resistance to infections. The study aims to characterize patients attending a specialized Gut Microbiota Clinic that offers personalized microbiome-based treatments for various intestinal and extra-intestinal conditions. Despite growing interest and potential therapeutic uses of microbiome modulation like fecal microbiota transplantation, clinical integration remains limited due to complexity and lack of guidelines. The clinic at Fondazione Policlinico Gemelli evaluates patients with gastrointestinal disorders such as irritable bowel syndrome and inflammatory bowel diseases, as well as patients with autoimmune and oncological conditions. Patients undergo gut microbiome testing using a commercial test, and treatments are personalized based on microbiota profiling. The study will enroll approximately 400 patients attending the clinic to collect clinical and microbiological data. Participants will be monitored through routine clinical visits including follow-ups with specialists and assessments using validated disease-specific scores. Researchers will analyze changes in microbiota composition and clinical outcomes over 24 months, establishing a microbiological database. The study includes evaluations of pain intensity and specific disease activity indices to better understand treatment effects and patient profiles.

Outcomes of Outpatients in an Gut Microbiota Clinic