The Gut Virome as a Trigger for IBD: From Metagenomics to Pathogenesis

NCT05906680 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 69

Last updated 2023-06-18

No results posted yet for this study

Summary

Alterations in the composition of the intestinal microbiota (dysbiosis) are well known involved in the pathogenesis of gastrointestinal disorders, such as inflammatory bowel disease (IBD), which includes ulcerative colitis (UC) and Crohn's disease (CD). While bacteria have always gotten the most attention in gastrointestinal disorders, the viral component of the human gut microbiome, called the "gut virome", is underestimated. In addition to bacteriophages, the gut virome also harbors viruses that infect eukaryotic cells, capable of transferring their information directly to host cells, and associated with the pathogenesis of both UC and CD.

Although a substantial number of studies have described the viral composition of gut microbiota in human feces, it is necessary to define the entire eukaryotic virome which colonizes the intestinal mucosa of patients with inflammatory bowel disease and which intestinal cell population is most affected. Therefore, this study aims at a comprehensive metagenomic analysis on single cells of the intestinal mucosa from a large cohort of treatment-naïve young patients with IBD at their first diagnosis to find out which cells are affected by eukaryotic viruses in the early stages of the onset of IBD and how it can affect the immune response of the mucosa, eventually leading to chronic intestinal inflammation.

Conditions

Interventions

PROCEDURE

Additional biopsies collection

We will recruit only subjects (UC, CD and NO-UC/CD) scheduled for the endoscopy and biopsies-collection according to the usual clinical practice. During the endoscopy we will collect 6 additional biopsies.

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-07
Primary Completion
2024-03-31
Completion
2024-03-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05906680 on ClinicalTrials.gov