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Outcomes of Outpatients in an Gut Microbiota Clinic

ConditionIntestinal Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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 and cytokine 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

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years.

Patients attending the Microbiota Outpatient Clinic at Fondazione Policlinico Universitario "A. Gemelli" IRCCS.

Ability to understand the study procedures and provide written informed consent.

Patients for whom gut microbiota testing has been requested as part of routine clinical care.

Disqualifiers

Age <18 years.

Severe psychiatric disorders that may interfere with study participation or informed consent.

Inability to provide written informed consent.

Trial population

Outpatients attending the Gut Microbiota Clinic at Fondazione Policlinico Universitario "A. Gemelli" IRCCS

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Microbiome testing and Cytokine profiling

    Other intervention

    * Gut microbiome testing for the characterization of the patient gut microbiome * Oral microbiota profiling using saliva samples collected with DNA/RNA Shield Collection Tubes with Swabs. * Cytokine profiling using peripheral venous blood samples.

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: Cohort1 intervention

Trial outcomes

Primary outcomes

1

Microbiological Characteristics of Patients at the Gut Microbiota Clinic

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)

Time frame
24 months

Secondary outcomes

1

Changes in Microbiota Composition in Patients Undergoing Routine Clinical Microbiota Testing After Standard Treatments

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).

Time frame
24 months
2

Assessment of CDAI Scores

Crohn's Disease Activity Index (CDAI) for Crohn's disease (Range: 0-600; higher scores indicate worse disease activity)

Time frame
24 months
3

Assessment of IBS-SSS

IBS Severity Scoring System (IBS-SSS) for irritable bowel syndrome (Range: 0-500; higher scores indicate worse symptoms).

Time frame
24 months
4

Assessment of PFS Scores

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.

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead sponsor

Source ClinicalTrials.gov
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