Outcomes of Outpatients in an Gut Microbiota Clinic
Recruiting now
Conditions studied: Intestinal Disease
In brief
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.
Key facts
- Study ID
- NCT06845527
- Run by
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- People needed
- 400
- Starts
- 2025-03-13
- Expected to finish
- 2027-03-10
- Last updated by the study team
- 2026-07-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥18 years.
- Patients attending the Microbiota Outpatient Clinic at Fondazione Policlinico Universitario "A. Gemelli" IRCCS.
- Ability to understand the study procedures and provide written informed consent.
- Patients for whom gut microbiota testing has been requested as part of routine clinical care.
You may not qualify if…
- Age <18 years.
- Severe psychiatric disorders that may interfere with study participation or informed consent.
- Inability to provide written informed consent.
Where it is running
- Policlinico Universitario Agostino Gemelli IRCCS — Rome, RM, Italy (enrolling)
Full record on ClinicalTrials.gov
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