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Study identifier: NCT06845527 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Outcomes of Outpatients in an Gut Microbiota Clinic

Condition: Intestinal Disease  ·  Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

PhaseN/A
Planned participants400
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

The gut microbiota plays a crucial role in human health, influencing metabolism, immunity, and pathogen resistance. Research has linked microbiome dysbiosis to various intestinal and extra-intestinal disorders, prompting interest in therapeutic strategies like fecal microbiota transplantation (FMT), which is now standard for recurrent Clostridioides difficile infection and shows promise for other conditions. Despite its potential, the clinical integration of microbiome research remains limited due to biological complexity, lack of clinician awareness, and the absence of standardized guidelines. Meanwhile, patient demand for microbiome-based interventions is rising, leading some to seek non-scientific alternatives with potential health risks. Since 2016, the Gut Microbiota Clinic at Fondazione Policlinico Gemelli has provided personalized microbiota-based treatments, collaborating with specialists across disciplines. The clinic primarily serves patients with gastrointestinal and extra-intestinal disorders and employs a multidisciplinary approach. This study aims to characterize the clinical and microbiological and cytokine profiles of patients attending the clinic and establish a microbiological database. Primary and secondary endpoints include microbiota composition changes and clinical outcomes assessed through validated diagnostic tools.

This description comes directly from the study's public registry record.

Talk to the study team

Gianluca Ianiro, MD, PhD  ·  0630159539  ·  gianluca.ianiro@unicatt.it

Serena Porcari, MD, PhD  ·  0630159539  ·  serena.porcari@policlinicogemelli.it

Always discuss trial participation with your own doctor first.

Locations (1)

Policlinico Universitario Agostino Gemelli IRCCSRome, RM, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT06845527