Clinical trial NCT06845527: Outcomes of Outpatients in an Gut Microbiota Clinic
Official title: Characteristics and Outcomes of Outpatients Referred to an Gut Microbiota Clinic
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intestinal Disease
Keywords: Gut Dysbiosis
Microbiome testing
Microbiome
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients attending the Gut Microbiota Clinic at Fondazione Policlinico Universitario "A. Gemelli" IRCCS 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.

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.

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

Primary outcomes:
measure: Microbiological Characteristics of Patients at the Gut Microbiota Clinic
timeFrame: 24 months
Secondary outcomes:
measure: Changes in Microbiota Composition in Patients Undergoing Routine Clinical Microbiota Testing After Standard Treatments
timeFrame: 24 months
measure: Assessment of CDAI Scores
timeFrame: 24 months
measure: Assessment of IBS-SSS
timeFrame: 24 months
measure: Assessment of PFS Scores
timeFrame: 24 months
measure: Pain intensity
timeFrame: 24 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Universitario Agostino Gemelli IRCCS
state: RM
Study officials:
References:
citation: Lin D, Medeiros DM. The microbiome as a major function of the gastrointestinal tract and its implication in micronutrient metabolism and chronic diseases. Nutr Res. 2023 Apr;112:30-45. doi: 10.1016/j.nutres.2023.02.007. Epub 2023 Mar 4.
citation: Ghosh S, Whitley CS, Haribabu B, Jala VR. Regulation of Intestinal Barrier Function by Microbial Metabolites. Cell Mol Gastroenterol Hepatol. 2021;11(5):1463-1482. doi: 10.1016/j.jcmgh.2021.02.007. Epub 2021 Feb 18.
citation: Zhang D, Jian YP, Zhang YN, Li Y, Gu LT, Sun HH, Liu MD, Zhou HL, Wang YS, Xu ZX. Short-chain fatty acids in diseases. Cell Commun Signal. 2023 Aug 18;21(1):212. doi: 10.1186/s12964-023-01219-9.
citation: Horrocks V, King OG, Yip AYG, Marques IM, McDonald JAK. Role of the gut microbiota in nutrient competition and protection against intestinal pathogen colonization. Microbiology (Reading). 2023 Aug;169(8):001377. doi: 10.1099/mic.0.001377.
citation: Martin AM, Sun EW, Rogers GB, Keating DJ. The Influence of the Gut Microbiome on Host Metabolism Through the Regulation of Gut Hormone Release. Front Physiol. 2019 Apr 16;10:428. doi: 10.3389/fphys.2019.00428. eCollection 2019.
citation: Pedersen HK, Gudmundsdottir V, Nielsen HB, Hyotylainen T, Nielsen T, Jensen BA, Forslund K, Hildebrand F, Prifti E, Falony G, Le Chatelier E, Levenez F, Dore J, Mattila I, Plichta DR, Poho P, Hellgren LI, Arumugam M, Sunagawa S, Vieira-Silva S, Jorgensen T, Holm JB, Trost K; MetaHIT Consortium; Kristiansen K, Brix S, Raes J, Wang J, Hansen T, Bork P, Brunak S, Oresic M, Ehrlich SD, Pedersen O. Human gut microbes impact host serum metabolome and insulin sensitivity. Nature. 2016 Jul 21;535(7612):376-81. doi: 10.1038/nature18646. Epub 2016 Jul 13.
citation: Pandey H, Jain D, Tang DWT, Wong SH, Lal D. Gut microbiota in pathophysiology, diagnosis, and therapeutics of inflammatory bowel disease. Intest Res. 2024 Jan;22(1):15-43. doi: 10.5217/ir.2023.00080. Epub 2023 Nov 8.
citation: Yuan Y, Wang X, Huang S, Wang H, Shen G. Low-level inflammation, immunity, and brain-gut axis in IBS: unraveling the complex relationships. Gut Microbes. 2023 Dec;15(2):2263209. doi: 10.1080/19490976.2023.2263209. Epub 2023 Oct 2.
citation: Moayyedi P, Surette MG, Kim PT, Libertucci J, Wolfe M, Onischi C, Armstrong D, Marshall JK, Kassam Z, Reinisch W, Lee CH. Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial. Gastroenterology. 2015 Jul;149(1):102-109.e6. doi: 10.1053/j.gastro.2015.04.001. Epub 2015 Apr 7.
citation: Rossen NG, Fuentes S, van der Spek MJ, Tijssen JG, Hartman JH, Duflou A, Lowenberg M, van den Brink GR, Mathus-Vliegen EM, de Vos WM, Zoetendal EG, D'Haens GR, Ponsioen CY. Findings From a Randomized Controlled Trial of Fecal Transplantation for Patients With Ulcerative Colitis. Gastroenterology. 2015 Jul;149(1):110-118.e4. doi: 10.1053/j.gastro.2015.03.045. Epub 2015 Mar 30.
citation: Paramsothy S, Kamm MA, Kaakoush NO, Walsh AJ, van den Bogaerde J, Samuel D, Leong RWL, Connor S, Ng W, Paramsothy R, Xuan W, Lin E, Mitchell HM, Borody TJ. Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial. Lancet. 2017 Mar 25;389(10075):1218-1228. doi: 10.1016/S0140-6736(17)30182-4. Epub 2017 Feb 15.
citation: El-Salhy M, Hatlebakk JG, Gilja OH, Brathen Kristoffersen A, Hausken T. Efficacy of faecal microbiota transplantation for patients with irritable bowel syndrome in a randomised, double-blind, placebo-controlled study. Gut. 2020 May;69(5):859-867. doi: 10.1136/gutjnl-2019-319630. Epub 2019 Dec 18.