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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06149949
Acronym
PRIME
Enrollment
100
Registered
2023-11-29
Start date
2024-01-01
Completion date
2025-06-30
Last updated
2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal Inflammation, Rhinosinusitis

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.

Interventions

OTHERObservational 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

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
prevalence of chronic rhinosinusitis in patients with chronic inflammatory bowel disease1 hourTo define the prevalence of chronic rhinosinusitis in patients with chronic inflammatory bowel disease

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026