Clinical Trials in Italy / NCT06720961
Starting soon Observational

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

NCT06720961 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-04
Last updated
2025-02-14

Condition(s) studied

Crohn Disease (CD)

Investigational drug(s) / intervention(s)

Collection of surgical specimenCollection of stool sample

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
69 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Adult patients ≥18 and \<70 years * Patients able to autonomously sign the informed consent * Non pregnant or breastfeeding patients * For CD patients: CD patients with established diagnosis and additionally classified according to 3 stages: B1 (more inflammatory, non-stricturing), B2 (stricturing, non-penetrating) and B3 (stricturing and penetrating). Patients will be stratified on the basis of CT, MRI or ultrasound analysis (stratification already known before surgery) * For non-IBD patients: patients with other pathologies but not affected by IBD according to the previously reported clinical and endoscopic evaluation criteria (ex. diverticulitis) Exclusion Criteria: * Patients \<18 years or \> 70 years * Pregnant or breastfeeding patients * For CD Patients: Subjects with CD who do not meet evaluation criteria described above * For non-IBD patients: Patients undergoing anti-inflammatory and/or immunosuppressive treatments for IBD-related diseases

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
IRCCS San Raffaele Milan Italy

More IRCCS San Raffaele trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06720961 on ClinicalTrials.gov ↗ ← All trials in Italy