Last reviewed · How we verify
NCT05906680
The Gut Virome as a Trigger for IBD: From Metagenomics to Pathogenesis
trial testing Additional biopsies collection in IBD in 69 participants. Status unknown.
31 March 2024
Quick facts
| Lead sponsor | IRCCS San Raffaele |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 69 |
| Start date | 7 February 2023 |
| Primary completion | 31 March 2024 |
| Estimated completion | 31 March 2024 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Additional biopsies collection
Conditions studied
- IBD — all drugs for IBD →
Sponsor
IRCCS San Raffaele — full company profile →
Who can join
Adults 18 to 40, any sex, with IBD. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05906680
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05906680 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by IRCCS San Raffaele
- Last refreshed: 18 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05906680.
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