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NCT06149949 | NOT YET RECRUITING | Intestinal Inflammation

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

Agostino Gemelli IRCCS University Polyclinic University Foundation

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.

Condition or disease

Intestinal Inflammation

Rhinosinusitis

Intervention/treatment

Observational study

Study Type : OBSERVATIONAL
Estimated Enrollment : 100 participants
Official Title : Ambispective Pilot Study on the Prevalence of Chronic Rhinosinusitis Associated With Inflammatory Bowel Disease and Association With Biomarkers of Epithelial Barrier Damage
Actual Study Start Date : 2024-01-01
Estimated Primary Completion Date : 2024-06-30
Estimated Study Completion Date : 2025-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
    • the Prevalence of Chronic Rhinosinusitis Associated With Inflammatory Bowel Disease and Association With Biomarkers of Epithelial Barrier Damage

    Location Details

    NCT06149949

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    How to Participate

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    Locations

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