Outcomes of Outpatients in an Gut Microbiota Clinic

Recruiting

• Conditions: Intestinal Disease

• Registration Number: NCT06845527
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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 extra-intestinal conditions. 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) will be used for patients with intestinal disorders.

* 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.

Study Timeline

• Study First Submitted: 2025-02-06
• Study First Submitted QC: 2025-02-24
• Study First Posted: 2025-02-25
• Status Verified: 2025-03
• Study Start: 2025-03-13
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19
• Primary Completion: 2027-03-10
• Study Completion: 2027-03-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
Changes in Microbiota Composition in Patients Undergoing Routine Clinical Microbiota Testing After Standard Treatments	24 months	To describe changes in microbiota composition in patients undergoing microbiome testing as part of routine clinical practice after receiving standard treatments (Alpha and beta diversity, Taxonomic Composition - Proportion of different bacterial phyla, genera, and species).
Assessment of CDAI Scores	24 months	Crohn's Disease Activity Index (CDAI) for Crohn's disease (Range: 0-600; higher scores indicate worse disease activity)
Assessment of PFS Scores	24 months	Variation of of Progression-Free Survival (PFS) in cancers patients treated with immunotherapy or targeted therapies: In selected patients with a sustained response, PFS can exceed 24 to 48 months.
Assessment of IBS-SSS	24 months	IBS Severity Scoring System (IBS-SSS) for irritable bowel syndrome (Range: 0-500; higher scores indicate worse symptoms).
Pain intensity	24 months	The Visual Analog Scale (VAS) for Pain is a continuous scale, usually 10 cm long, where the patient marks the point that best represents their pain intensity. Scores range from 0 (no pain) to 10 (worst possible pain).

Trial Locations

Locations (1)

Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Rome, RM, Italy