Evaluation of the Accuracy of Immunostaining of Claudin 2 to Detect Active or Inactive Inflammation in Endoscopic Biopsies of IBD

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 IBD. The aim is compare the accuracy of this methodology and in addition the correlation with outcomes (i.e. relapse, hospitalization, surgery).

NCT Number	NCT07710287
Lead Sponsor	IRCCS Policlinico S. Donato Collaborators: Asst Degli Spedali Civili Di Brescia
Conditions	Ulcerative Colitis (UC), Crohn Disease
Enrollment	100 participants
Start Date	2025-02-14
Primary Completion	2027-02 (estimated)
Study Completion	2027-09 (estimated)
Updated on ClinicalTrials.gov	2026-07-17