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

Rhinosinusitis Clinical Trial

— PRIME  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06149949
• Other study ID #: 6126
• Status: Not yet recruiting
• Start date: January 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: November 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Eligibility Criteria

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

Related Conditions & MeSH terms

• Inflammation
• Inflammatory Bowel Diseases
• Intestinal Inflammation
• Rhinosinusitis
• Sinusitis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of chronic rhinosinusitis in patients with chronic inflammatory bowel disease	To define the prevalence of chronic rhinosinusitis in patients with chronic inflammatory bowel disease	1 hour