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