Understanding patient outcomes in a Gut Microbiota Clinic

Characteristics and Outcomes of Outpatients Referred to an Gut Microbiota Clinic

This study looks at how personalized gut treatments can help people with intestinal diseases by testing their gut microbiome and seeing how well these treatments work.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Academic / other)
• Locations: 1 site (Rome, RM)
• Trial ID: NCT06845527 on ClinicalTrials.gov

What this trial studies

This observational study focuses on patients attending the Gut Microbiota Clinic at Fondazione Policlinico Gemelli, where personalized microbiota-based treatments are provided. It aims to explore the role of gut microbiome testing in diagnosing and treating intestinal diseases, including conditions like recurrent Clostridioides difficile infection and irritable bowel syndrome. The study will assess the effectiveness of these interventions and the integration of microbiome research into clinical practice. By analyzing patient outcomes, the study seeks to bridge the gap between microbiome science and routine healthcare.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are attending the Gut Microbiota Clinic and have undergone gut microbiota testing.

Not a fit: Patients under 18 years old or those with severe psychiatric disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding and treatment of intestinal diseases through personalized microbiome interventions.

How similar studies have performed: While the integration of microbiome research into clinical practice is still developing, there have been successful studies demonstrating the efficacy of microbiome-based treatments like fecal microbiota transplantation.

Eligibility criteria

Inclusion Criteria:

* Age ≥18 years;
* Patient attending the Gut Microbiota Clinic at Fondazione Policlinico Universitario "A. Gemelli" IRCCS;
* Ability to provide informed consent for inclusion in the study;
* Patient in possession of a gut microbiota test, performed as part of routine clinical practice upon medical request, no more than one month prior to the first visit.

Exclusion Criteria:

* Age \< 18 years;
* Severe psychiatric disorders;
* Inability to provide informed conse

Where this trial is running

Rome, RM

• Policlinico Universitario Agostino Gemelli IRCCS — Rome, Rm, Italy (Recruiting)

Study contacts

• Study coordinator: Gianluca Ianiro, MD, PhD

Conditions Intestinal Disease; Gut Dysbiosis; Microbiome testing; Microbiome