Exploring the role of gut viruses in inflammatory bowel disease
The Gut Virome as a Trigger for IBD: From Metagenomics to Pathogenesis
IRCCS San Raffaele · NCT05906680
This study is trying to see how viruses in the gut might affect people with inflammatory bowel disease, like ulcerative colitis and Crohn's disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 69 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | IRCCS San Raffaele (other) |
| Locations | 1 site (Milan) |
| Trial ID | NCT05906680 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the gut virome's role in the pathogenesis of inflammatory bowel disease (IBD), specifically ulcerative colitis (UC) and Crohn's disease (CD). It aims to characterize the eukaryotic virome present in the intestines of affected patients and understand which intestinal cell populations are most impacted. By collecting additional biopsies during standard endoscopic procedures, the study seeks to provide insights into the viral components of the gut microbiome that may contribute to IBD. The findings could enhance our understanding of the complex interactions between gut viruses and host cells in gastrointestinal disorders.
Who should consider this trial
Good fit: Ideal candidates include treatment-naive patients aged 18 to 40 with a diagnosis of UC or CD undergoing endoscopy and biopsy collection.
Not a fit: Patients with previously documented gastrointestinal infections or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new insights into the role of gut viruses in IBD, potentially informing future therapeutic strategies.
How similar studies have performed: While the role of bacteria in IBD has been extensively studied, the exploration of the gut virome is relatively novel, suggesting this approach is less tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: SUBJECTS AFFECTED BY UC OR CD: * subjects undergoing endoscopy and biopsies-collection according to the standard of care first diagnosis for UC or CD, treatment naive patients (≥18 and \<40 years) * no previously documented gastrointestinal infections Furthermore, for subjects with UC: - clinical and endoscopic evaluation (Mayo score≥2) Furthermore, for subjects with CD: - clinical and endoscopic evaluation (Harvey-Bradshaw score≥5 and overall Simplified Endoscopic Score (SES-CD)\> 2) SUBJECTS NOT AFFECTED BY UC OR CD (CONTROL GROUP): * subjects undergoing endoscopy and biopsies-collection according to the standard of care (≥18 and \<40 years) (for example patients in screening for colorectal cancer disease.) * subjects not affected by UC or CD according to the previously reported clinical and endoscopic evaluation criteria All patients will be asked to sign the written informed consent. Exclusion Criteria: SUBJECTS AFFECTED BY UC OR CD: * subjects with UC or CD who do not respect the clinical and endoscopic evaluation criteria previously described * subjects with UC or CD who respect the clinical and endoscopic evaluation criteria BUT previously treated with/undergoing anti-inflammatory and/or immunosuppressive drugs SUBJECTS NOT AFFECTED BY UC OR CD (CONTROL GROUP): - subjects undergoing anti-inflammatory and/or immunosuppressive treatments for other diseases not related to UC or CD
Where this trial is running
Milan
- IRCCS Ospedale San Raffaele — Milan, Italy (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: IBD, Gut virome, Intestinal Bowel Disease