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

NCT06149949 | Unknown

• 1 other identifier: 6126
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intestinal Inflammation; Rhinosinusitis

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Observational study OTHER

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

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with intestinal bowel disease afferent to our outpatient chronic inflammatory bowel disease clinic at CEMAD will be enrolled. All patients will be given questionnaires at baseline on quality of life and symptoms of intestinal bowel disease and the presence of symptoms correlated with rhinosinusitis cronic. Patients who respond affirmatively to the presence of rhinosinus symptoms will have their blood drawn according to clinical practice and deliver a stool sample for gut microbiota analysis. In addition, all will undergo psychological evaluation. Patients with rhinosinusitis cronic will undergo specialist otolaryngologist evaluation according to clinical practice.

You may qualify if:

• 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

You may not qualify if:

• Age \<18 years
• Refusal of informed consent

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Rhinosinusitis

Interventions

Observation

Condition Hierarchy (Ancestors)

Rhinitis; Respiratory Tract Infections; Infections; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: November 29, 2023
• Study Start: January 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: November 29, 2023

Record last verified: 2023-11