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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06149949
Collaborator
(none)
100
Enrollment
17.9
Anticipated Duration (Months)

Study Details

Study Description

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 Intervention/Treatment Phase
  • Other: Observational study

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Ambispective Pilot Study on the Prevalence of Chronic Rhinosinusitis Associated With Inflammatory Bowel Disease and Association With Biomarkers of Epithelial Barrier Damage
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2025

Outcome Measures

Primary Outcome Measures

  1. prevalence of chronic rhinosinusitis in patients with chronic inflammatory bowel disease [1 hour]

    To define the prevalence of chronic rhinosinusitis in patients with chronic inflammatory bowel disease

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier:
NCT06149949
Other Study ID Numbers:
  • 6126
First Posted:
Nov 29, 2023
Last Update Posted:
Nov 29, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Sinusitis
Inflammatory Bowel Diseases
Inflammation

Study Results

No Results Posted as of Nov 29, 2023