Airway Involvement In Inflammatory Bowel Disease

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06090045

Collaborator

(none)

Enrollment

13.2

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

To estimate prevalence of subclinical airway injuries among IBD patients. To investigate relationship between activity of IBD and airways

Condition or Disease	Intervention/Treatment	Phase
IBD

Detailed Description

Airway diseases are the most commonly described lung manifestations of inflammatory bowel disease (IBD). However, the similarities in disease pathogenesis and the sharing of important environmental risk factors and genetic susceptibility suggest that there is a complex interplay between IBD and airway diseases.Extraintestinal manifestations (EIM) commonly occur in inflammatory bowel diseases (IBD), with a prevalence rate between 21%-41% reported in various series. Crohn's disease (CD) presents with EIM more frequently than ulcerative colitis (UC). Pulmonary involvement complicating IBD was originally considered rare (with a frequency rate < 1%), but the first case series published in 1976 assisted in better recognition, evaluation and description of IBD related respiratory disease. Pulmonary involvement is often asymptomatic and may be detected solely on the basis of abnormal screening tests. This review will focus on the involvement of the airways in the context of IBD. Although IBD related PM were originally considered rare, certain population-based studies have revealed significant interrelationships between the lungs and IBD. Bernstein and colleagues in a large population-based study in North America in 2005 reported that airway disorders in general (including asthma and bronchitis) were the most common extraintestinal manifestation in subjects with CD and the second most common in subjects with UC, with the prevalence of asthma in this population between 7%-8%. In another retrospective study from the opposite view, Birring reported that IBD was 4 times more prevalent among patients with airway diseases, particularly non-asthmatic patients with productive cough, than in the general population.

Study Design

Study Type:

Observational

Anticipated Enrollment :

70 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Spectrum Of Airway Involvement In Inflammatory Bowel Disease

Anticipated Study Start Date :

Nov 20, 2023

Anticipated Primary Completion Date :

Nov 20, 2024

Anticipated Study Completion Date :

Dec 25, 2024

Outcome Measures

Primary Outcome Measures

Predictors of airway diseases in patients with IBD [baseline]
FROM risk factors

Secondary Outcome Measures

-Prevalence of of subclinical airway injuries among IBD patients presented to Tropical Department in Assiut University Hospital [baseline]
from statistical anyalasis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Patients attended to IBD clinic at Tropical Department

Exclusion Criteria:

Age: less than 18 years
Unstable patients or need for ICU admission

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

Study Chair: Marwa Salama, MD, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Hend Mohamed Sayed Mohamed, Lecture, Assiut University

ClinicalTrials.gov Identifier:

NCT06090045

Other Study ID Numbers:

IBD&Airway

First Posted:

Oct 19, 2023

Last Update Posted:

Oct 19, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Inflammatory Bowel Diseases

Study Results

No Results Posted as of Oct 19, 2023