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

November 21, 2023 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of chronic rhinosinusitis in patients with chronic inflammatory bowel disease
Time Frame: 1 hour
To define the prevalence of chronic rhinosinusitis in patients with chronic inflammatory bowel disease
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

November 21, 2023

First Submitted That Met QC Criteria

November 21, 2023

First Posted (Actual)

November 29, 2023

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6126 (CTEP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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