Outcomes of Outpatients in an Gut Microbiota Clinic

Condition(s) studied

Investigational drug(s) / intervention(s)

Microbiome testing and Cytokine profiling: * Gut microbiome testing for the characterization of the patient gut microbiome * Oral microbiota profiling using saliva samples collected with DNA/RNA Shield Collection Tubes with Swabs. * Cytokine profiling using peripheral venous blood samples.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Microbiological Characteristics of Patients at the Gut Microbiota Clinic — 24 months
  The microbiome test results that patients will bring to the visit will be analyzed, including: Alpha and beta diversity Taxonomic Composition (proportion of different bacterial phyla, genera, and species)

Trial sites (1)

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