Actively Recruiting

Age: 18Years +
All Genders
NCT06845527

Outcomes of Outpatients in an Gut Microbiota Clinic

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-07-15

400

Participants Needed

1

Research Sites

103 weeks

Total Duration

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AI-Summary

What this Trial Is About

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 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.

CONDITIONS

Official Title

Outcomes of Outpatients in an Gut Microbiota Clinic

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Attending the Gut Microbiota Clinic at Fondazione Policlinico Universitario "A. Gemelli" IRCCS
  • Able to provide informed consent for the study
  • Have a gut microbiota test performed within one month before the first visit as part of routine care
Not Eligible

You will not qualify if you...

  • Younger than 18 years
  • Severe psychiatric disorders
  • Unable to provide informed consent

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Policlinico Universitario Agostino Gemelli IRCCS

Rome, RM, Italy, 00168

Actively Recruiting

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Research Team

G

Gianluca Ianiro, MD, PhD

CONTACT

S

Serena Porcari, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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