Outcomes of Outpatients in an Gut Microbiota Clinic

NCT06845527 | Recruiting

• 1 other identifier: ID 6778
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Intestinal Disease

Keywords

Gut Dysbiosis; Microbiome testing; Microbiome

Outcome Measures

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)

  24 months

Secondary Outcomes (6)

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

  24 months

• Assessment of CDAI Scores

  24 months

• Assessment of IBS-SSS

  24 months

• Assessment of PFS Scores

  24 months

• Pain intensity

  24 months

Study Arms (1)

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.

Other: Gut microbiome testing

Interventions

Gut microbiome testing OTHER

Gut microbiome testing for the characterization of the patient gut microbiome

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥18 years;
• Patient attending the Gut Microbiota Clinic at Fondazione Policlinico Universitario "A. Gemelli" IRCCS;
• 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.

You may not qualify if:

• Age \< 18 years;
• Severe psychiatric disorders;
• Inability to provide informed conse

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Policlinico Universitario Agostino Gemelli IRCCS

Rome, RM, 00168, Italy

RECRUITING

Related Publications (12)

• 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.

  PMID: 36965327 BACKGROUND

• 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.

  PMID: 33610769 BACKGROUND

• 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.

  PMID: 37596634 BACKGROUND

• 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.

  PMID: 37540126 BACKGROUND

• 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.

  PMID: 31057420 BACKGROUND

• 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.

  PMID: 27409811 BACKGROUND

• 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.

  PMID: 37935653 BACKGROUND

• 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.

  PMID: 37786296 BACKGROUND

• 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.

  PMID: 25857665 BACKGROUND

• 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.

  PMID: 25836986 BACKGROUND

• 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.

  PMID: 28214091 BACKGROUND

• 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.

  PMID: 31852769 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

stool samples

MeSH Terms

Conditions

Intestinal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Gianluca Ianiro, MD, PhD

CONTACT

0630159539; gianluca.ianiro@unicatt.it

Serena Porcari, MD, PhD

CONTACT

0630159539; serena.porcari@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 25, 2025
• Study Start: March 13, 2025
• Primary Completion (Estimated): March 10, 2027
• Study Completion (Estimated): March 10, 2027
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Access Criteria: Data will be given upon reasonable request to the PI

Locations

IT (1)