Crohn'sNot yet recruiting
The Microbial Impact on Intestinal Fibrosis and the Associated Immune Microenvironment in Crohn's Disease
Observational · No treatment assigned · 1 site · IRCCS San Raffaele
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn Disease (CD). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 69
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- Adult patients ≥18 and <70 years
- Patients able to autonomously sign the informed consent
- Non pregnant or breastfeeding patients
Plus 2 more requirement(s). There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 20 participants are expected to take part.
- Start date: 2025-04 (planned).
- Main results expected around 2026-01 (estimate from the record).
- 1 study site listed in Italy.
Main thing being measured
- To identify the cellular subtypes and molecular pathways impacted by the specific bacterial factors during CD-associated fibrosis. (Experiments and analysis: 11th to 36th month)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn Disease (CD) |
| Lead sponsor | IRCCS San Raffaele |
| Collaborators | University of Florence; Humanitas Research Hospital IRCCS, Rozzano-Milan; Ministero dell'Istruzione, dell'Università e della Ricerca; Università Vita-Salute San Raffaele |
| Enrollment | 20 (estimated) |
| Start date | 2025-04 |
| Primary completion (est.) | 2026-01 |
| First posted | 2024-12-06 |
| Last updated | 2025-02-14 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT06720961 |
Interventions
- Collection of surgical specimen (Procedure)
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… - Collection of stool sample (Procedure)
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.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS San Raffaele | Milan, Italy | Italy |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.