NCT06720961Not yet recruiting
The Microbial Impact on Intestinal Fibrosis and the Associated Immune Microenvironment in Crohn's Disease
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
Source: ClinicalTrials.gov · Last updated 14 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 3 Dec 2024
- Start date
- Apr 2025
- Primary completion date
- Jan 2026
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Crohn's disease
- NCT number
- NCT06720961
What you commit to
- Study type: Observational
- Planned participants: 20
- From Apr 2025 to the primary completion date, Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- For non-IBD patients: Patients undergoing anti-inflammatory and/or immunosuppressive treatments for IBD-related diseases
Age
- Patients \<18 years or \> 70 years
Other
- Pregnant or breastfeeding patients
- For CD Patients: Subjects with CD who do not meet evaluation criteria described above
Who the study is looking for
- 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)
Age in the registry: 18 years to 69 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.