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

Not yet recruiting

• Conditions: Rhinosinusitis; Intestinal Inflammation

• Registration Number: NCT06149949
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-21
• Study First Submitted QC: 2023-11-21
• Last Update Submitted: 2023-11-21
• Study First Posted: 2023-11-29
• Last Update Posted: 2023-11-29
• Study Start: 2024-01-01
• Primary Completion: 2024-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age between 18 years and 70 years.
• Diagnosis of Crohn's disease or Ulcerative Rectocolitis
• Willingness to participate in the study and ability to comply with and understand the study protocol.
• Patients with a previous diagnosis of Crohn's disease or Ulcerative Rectocolitis for at least 3 months prior to screening
• Signature of informed consent

Exclusion Criteria

• Age <18 years
• Refusal of informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
prevalence of chronic rhinosinusitis in patients with chronic inflammatory bowel disease	1 hour	To define the prevalence of chronic rhinosinusitis in patients with chronic inflammatory bowel disease