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
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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NOT_YET_RECRUITING
100 participants
OBSERVATIONAL
2024-01-01
2025-06-30
Brief Summary
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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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Study Design
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COHORT
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
Eligibility Criteria
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Inclusion Criteria
* 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
* Refusal of informed consent
18 Years
70 Years
ALL
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Other Identifiers
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6126
Identifier Type: -
Identifier Source: org_study_id