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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06149949
Other study ID # 6126
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date June 30, 2025

Study information

Verified date November 2023
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date June 30, 2025
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Intervention

Other:
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome

Type Measure Description Time frame Safety issue
Primary prevalence of chronic rhinosinusitis in patients with chronic inflammatory bowel disease To define the prevalence of chronic rhinosinusitis in patients with chronic inflammatory bowel disease 1 hour
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