NCT06845527 Outcomes of Outpatients in an Gut Microbiota Clinic
| NCT ID | NCT06845527 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Intestinal Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-03-13 |
| Primary Completion | 2027-03-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2025-03-13 with a primary completion date of 2027-03-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06845527 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intestinal Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06845527 currently recruiting?
Yes, NCT06845527 is actively recruiting participants. Contact the research team at gianluca.ianiro@unicatt.it for enrollment information.
Where is the NCT06845527 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06845527 clinical trial?
NCT06845527 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 400 participants.