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NCT06720961

The Microbial Impact on Intestinal Fibrosis and the Associated Immune Microenvironment in Crohn's Disease

Sponsor: IRCCS San Raffaele

View on ClinicalTrials.gov

Summary

The goal of this study is to find out if there is a direct connection between an imbalance of gut bacteria and the development of scar tissue in the gut by identifying important bacterial proteins found in scarred gut tissue. Our aim is to identify which types of cells and biological processes are affected by these bacterial proteins in people with Crohn's Disease. We will also study how these bacterial proteins cause changes in 3D models of gut fibrosis.

Official title: Unveiling the Microbial Impact on Intestinal Fibrosis and the Associated Immune Microenvironment: New Insights for the Pathogenesis and Treatment of Crohn's Disease-associated Complications

Key Details

Gender

All

Age Range

18 Years - 69 Years

Study Type

OBSERVATIONAL

Enrollment

20

Start Date

2025-04

Completion Date

2027-01

Last Updated

2025-02-14

Healthy Volunteers

Yes

Interventions

PROCEDURE

Collection of surgical specimen

Specimens of CD patients and non-IBD related patients will be collected during the surgery performed for clinical practice, without other risks for the patients, since we will use only leftover material after pathologist analysis. All of the collected surgical samples will be used for this project and, for this reason, they will not be conserved after the research period. Any residual samples will be destroyed.

PROCEDURE

Collection of stool sample

One week before the surgery to remove the stricture, fecal samples from CD patients belonging to B1, B2, B3 groups will be collected. They will be used for the exploratory objective. All of the collected fecal samples will be used for this project and, for this reason, they will not be conserved after the research period. Any residual samples will be destroyed.

Locations (1)

IRCCS San Raffaele

Milan, Italy, Italy