Evaluation of the Accuracy of Immunostaining of Claudin 2 to Detect Active or Inactive Inflammation in Endoscopic Biopsies of IBD
Observational · No treatment assigned · 1 site · IRCCS Policlinico S. Donato
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Ulcerative Colitis (UC) and Crohn Disease. 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 and older
- Any sex
Some of the main requirements, copied from the record:
- Confirmed diagnosis of IBD
There are also 1 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 100 participants are expected to take part.
- Start date: 2025-02-14.
- Main results expected around 2027-02 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Italy.
Main thing being measured
- Active/inactive inflammation (At enrolement)
In the researchers’ words
In view of the increasing evidence of the importance of mucosal healing as a combination of endoscopic and histologic healing, and the complexity and lack of complete agreement of the evaluation of histologic healing in IBD, the aim of this study will be to evaluate the accuracy of a new methodology, the immunostaining for Claudine 2 as compared to others standard well-accepted scoring for histologic activity in…
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 | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Ulcerative Colitis (UC); Crohn Disease |
| Lead sponsor | IRCCS Policlinico S. Donato |
| Collaborators | Asst Degli Spedali Civili Di Brescia |
| Enrollment | 100 (estimated) |
| Start date | 2025-02-14 |
| Primary completion (est.) | 2027-02 |
| First posted | 2026-07-17 |
| Last updated | 2026-07-17 |
| Official title | Histologic Healing in IBD: Comparison of "Standard" Scores With Expression of Claudin 2 and Impact on Outcomes |
| ClinicalTrials.gov ID | NCT07710287 |
Interventions
- None listed
Full eligibility criteria (from the record)
Inclusion Criteria: Confirmed diagnosis of IBD Exclusion Criteria: Unconfirmed diagnosis of IBD
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Gastroenterology IRCCS San Donato Policlinic | San Donato Milanese, Mi | Italy | Recruiting |
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.