NCT06149949

the Prevalence of Chronic Rhinosinusitis Associated With Inflammatory Bowel Disease and Association With Biomarkers of Epithelial Barrier Damage

Ambispective Pilot Study on the Prevalence of Chronic Rhinosinusitis Associated With Inflammatory Bowel Disease and Association With Biomarkers of Epithelial Barrier Damage

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to define the prevalence of chronic rhinosinusitis in patients with intestinal bowel disease. The main questions it aims to answer are: * Evaluate the influence of chronic rhinosinusitis on the quality of life of patients with intestinal bowel disease * Evaluate any relationships between chronic rhinosinusitis and the clinical course of intestinal bowel disease -Evaluate the influence of chronic rhinosinusitis on the response to biologic therapies for intestinal bowel disease * Evaluate mucosal barrier damage in patients with chronic rhinosinusitis and intestinal bowel disease by collecting blood and stool samples according to clinical practice * Presence of enterotoxin sensitization to S. Aureus in patients with intestinal bowel disease * Histopathological evaluation: reevaluation of biopsy slides performed according to clinical practice will be performed in patients with chronic rhinosinusitis and intestinal bowel disease in order to quantify the proportion of eosinophilic infiltrate at the intestinal level and to assess any differences from the population with intestinal bowel disease only. Patients with intestinal bowel disease afferent to our outpatient chronic inflammatory bowel disease clinic at CEMAD will be enrolled.

Conditions

• Intestinal Inflammation
• Rhinosinusitis

Interventions

Type	Name	Description
OTHER	Observational study	the aim of the study is to define the prevalence of rhinosinusitis cronic in intestinal bowel disease patients, to assess how it affects the patient's quality of life, and any correlations between these two entities

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-06-30
• Completion: 2025-06-30
• First posted: 2023-11-29
• Last updated: 2023-11-29