Outcomes of Outpatients in an Gut Microbiota Clinic

NCT ID: NCT06845527

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-13
• Study Completion Date: 2027-03-10

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.

Detailed Description

The gut microbiota is a key mediator of various human functions, including metabolism, the immune system, and resistance to pathogen colonization. A growing body of scientific research has demonstrated-initially through association studies and subsequently through mechanistic experiments-that gut microbiome dysbiosis is linked to a wide range of both intestinal and extra-intestinal disorders.

This body of evidence has led to the exploration of gut microbiome modulation as a therapeutic strategy, such as fecal microbiota transplantation (FMT), which has become a standard treatment for recurrent Clostridioides difficile infection and has also shown promise for several other indications, including ulcerative colitis, irritable bowel syndrome, and metabolic syndrome.

Furthermore, there is increasing interest in leveraging the gut microbiome as a diagnostic tool in clinical practice for various applications, including disease diagnosis, prognosis, and risk assessment; prediction of patient response to specific therapies; guidance and personalization of microbiome-targeted interventions such as probiotics or FMT; and monitoring the effectiveness of these treatments.

Despite this enthusiasm, however, the integration of microbiome research advancements into routine clinical practice remains generally limited. This gap can be attributed to several factors, primarily the complexity of microbiome biology, the limited knowledge of gut microbiota among most healthcare professionals, and the absence of established guidelines and infrastructures for the clinical application of microbiome research.

In contrast to the relatively slow adoption of microbiome research by clinicians, there is growing enthusiasm and high expectations among various patient groups for the rapid implementation of microbiota-related findings in clinical practice. This discrepancy poses the risk of patients seeking alternative, non-scientific solutions due to the lack of medical guidance. As a result, many individuals turn to non-medical sources, often found online, which may expose them to potential health risks and significant financial costs.

Since 2016, the Gut Microbiota Clinic has been active within the CEMAD (Center for Digestive Diseases) at Fondazione Policlinico Gemelli. This clinic was established to address the needs of patients with gut microbiota imbalances, offering personalized therapeutic approaches based on microbiota profiling, which is assessed using a commercially available test. In particular, Fondazione Policlinico Gemelli collaborates with the company XBIOGEM for the production and supply of gut microbiota tests.

The clinic primarily evaluates patients with gastrointestinal disorders (e.g., irritable bowel syndrome, inflammatory bowel diseases, and colitis induced by oncological treatments) as well as other conditions (e.g. patients with autoimmune disorders or patients undergoing oncological treatments). It operates through close collaboration with specialists from other medical fields, depending on the patient's condition (e.g., gastroenterologists, rheumatologists, dermatologists, infectious disease specialists, etc.), and follows a multidisciplinary approach involving dietitians and psychologists/psychiatrists as needed.

This clinic is highly specialized and innovative and, to the best of our knowledge, is the first dedicated clinic of its kind worldwide.

The aim of our study is to describe the characteristics of patients attending the Gut Microbiota Clinic at Fondazione Policlinico Gemelli and to establish a clinical and microbiological database. This initiative seeks to bridge the gap between the vast diagnostic and therapeutic potential of the gut microbiome and its practical application in routine clinical care.

OBJECTIVES

Primary Objective The primary objective is to describe the clinical and microbiological characteristics of patients attending the Gut Microbiota Clinic at Fondazione Policlinico Gemelli.

Secondary Objectives

• To describe changes in microbiota composition in patients undergoing microbiota testing as part of routine clinical practice after receiving standard treatments.
• To assess clinical changes by evaluating follow-up consultations with the referring specialist (e.g., rheumatologist or dermatologist) for patients with extra-intestinal conditions, or through the judgment of the responsible physician. When applicable, validated diagnostic scores specific to the relevant condition (e.g., Mayo Score for ulcerative colitis, CDAI for Crohn's disease, or IBS-SSS for irritable bowel syndrome, PFS and OS for oncological patients) will be used.
• To establish a microbiological database.

ENDPOINTS

Primary Endpoint The primary endpoint is the assessment of the clinical and microbiological characteristics of patients attending the Gut Microbiota Clinic at Fondazione Policlinico Gemelli.

Secondary Endpoints

• Changes in microbiota composition in patients undergoing microbiota testing as part of routine clinical practice after receiving standard treatments.
• Clinical variations assessed by referring specialists using validated and disease-specific diagnostic scores.

Conditions

Intestinal Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort

The study cohort will consist of patients attending the Gut Microbiota Clinic at Policlinico Gemelli in Rome. Patients with all inclusion criteria and none of the exclusion criteria will be considered for this study. N=400 patients will be enrolled. Since the study is interventional and the primary objective is descriptive, the sample size justification is based on the precision of confidence intervals. This sample size will allow the calculation of 95% confidence intervals for the considered point estimates; these intervals will have a precision of at least 5% for categorical variables and a precision equal to one-tenth of the standard deviation for quantitative variables.

Gut microbiome testing

Intervention Type: OTHER

Gut microbiome testing for the characterization of the patient gut microbiome

Interventions

Gut microbiome testing

Gut microbiome testing for the characterization of the patient gut microbiome

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

IANIRO GIANLUCA

Principal Investigator, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Policlinico Universitario Agostino Gemelli IRCCS

Rome, RM, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Gianluca Ianiro, MD, PhD

Role: CONTACT

gianluca.ianiro@unicatt.it

0630159539

Serena Porcari, MD, PhD

Role: CONTACT

serena.porcari@policlinicogemelli.it

0630159539

Facility Contacts

Gianluca Ianiro, MD, PhD

Role: primary

gianluca.ianiro@unicatt.it

0630159539

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Other Identifiers

ID 6778

Identifier Type: -

Identifier Source: org_study_id