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

NCT ID: NCT06149949

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-06-30

Brief Summary

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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

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Conditions

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Intestinal Inflammation Rhinosinusitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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6126

Identifier Type: -

Identifier Source: org_study_id