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

NCT06720961 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2025-02-14

No results posted yet for this 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.

Conditions

  • Crohn Disease (CD)

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.

Sponsors & Collaborators

  • University of Florence

    collaborator OTHER

  • Humanitas Research Hospital IRCCS, Rozzano-Milan

    collaborator OTHER

  • Ministero dell'Istruzione, dell'Università e della Ricerca

    collaborator UNKNOWN

  • Università Vita-Salute San Raffaele (MI)

    collaborator UNKNOWN

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • Silvio Danese, PhD-MD · IRCCS San Raffaele

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2026-01-31
Completion
2027-01-31

Countries

  • Italy

Study Locations

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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 NCT06720961 on ClinicalTrials.gov