Status:

NOT_YET_RECRUITING

Unveiling the Microbial Impact on Intestinal Fibrosis

Lead Sponsor:

IRCCS San Raffaele

Conditions:

Crohn Disease

Eligibility:

All Genders

18-70 years

Brief Summary

Crohn's disease (CD), belonging to the class of Inflammatory Bowel Diseases, is a chronic inflammatory disorder that may affect any location of the gastrointestinal tract. It is characterized by trans...

Detailed Description

This is a cross-sectional observational study involving patients with Crohn's Disease (CD) (n=15) and patients with non-Intestinal Bowel Disease (IBD) (n=5) undergoing surgery in the Gastroenterology ...

Eligibility Criteria

Inclusion

  • Adult patients ≥18 and \<70 years
  • All patients will sign the informed consent
  • Given that it is an observational study, also pregnant and breastfeed patients could be included
  • Additionally, for CD patients:
  • \- classification on different stages: (B1 (more inflammatory, non-structuring), B2 (structuring, non-penetrating) and B3 (structuring and penetrating). Patient stratification is based on previous classifications done in accordance with the standard of care through TC, RMI or Ecography.
  • Additionally, for non-IBD patients:
  • \- subjects undergoing surgery for non-IBD diseases (ex. diverticulitis) in accordance with the standard of care

Exclusion

  • For CD patients:
  • CD subjects without previously classification in B1, B2, B3
  • Patients \<18 years or \> 70 years
  • Patients without the signed informed consent
  • For non-IBD patients:
  • Patients \<18 years or \> 70 years
  • Patients without the signed informed consent

Key Trial Info

Start Date :

November 1 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

November 1 2026

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT06073288

Start Date

November 1 2023

End Date

November 1 2026

Last Update

October 10 2023

Active Locations (1)

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1

IRCCS Ospedale San Raffaele

Milan, Italy