NCT06090045

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

November 20, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2024

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

October 13, 2023

Last Update Submit

October 13, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Predictors of airway diseases in patients with IBD

    FROM risk factors

    baseline

Secondary Outcomes (1)

  • -Prevalence of of subclinical airway injuries among IBD patients presented to Tropical Department in Assiut University Hospital

    baseline

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

After taking the informed consent, full history will be taken from all patients participating in the study. Detailed clinical examination and routine laboratory investigations (complete blood count, liver function test, urea, creatinine and ESR) will be done Clinical notes will be obtain and review for all patients with a diagnosis of IBD (history of bowel surgery (for IBD, or indication not stated), use of 5-aminosalicylates or immunomodulators (if indication not stated) ). Diagnosis of IBD will confirm on the basis of a consistent clinical picture with endoscopic and histological confirmation, or characteristic radiological appearances. Airways disease will classify on the following grounds: asthma,.COPD:,Bronchiectasis,.Chronic bronchitis:

You may qualify if:

  • Patients attended to IBD clinic at Tropical Department

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Vutcovici M, Brassard P, Bitton A. Inflammatory bowel disease and airway diseases. World J Gastroenterol. 2016 Sep 14;22(34):7735-41. doi: 10.3748/wjg.v22.i34.7735.

    PMID: 27678355BACKGROUND
  • Byrd KM, Gulati AS. The "Gum-Gut" Axis in Inflammatory Bowel Diseases: A Hypothesis-Driven Review of Associations and Advances. Front Immunol. 2021 Feb 19;12:620124. doi: 10.3389/fimmu.2021.620124. eCollection 2021.

    PMID: 33679761BACKGROUND

Study Officials

  • Marwa Salama, MD

    Assiut University

    STUDY CHAIR

Central Study Contacts

Nermen Abuelkassem, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecture

Study Record Dates

First Submitted

October 13, 2023

First Posted

October 19, 2023

Study Start

November 20, 2023

Primary Completion

November 20, 2024

Study Completion

December 25, 2024

Last Updated

October 19, 2023

Record last verified: 2023-10