IBDNCT06090045
Airway Involvement In Inflammatory Bowel Disease
An observational study of IBD, run by Assiut University.
Trial summary
To estimate prevalence of subclinical airway injuries among IBD patients. To investigate relationship between activity of IBD and airways Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- IBD
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2023to 25 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
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:
Who may be able to join
- Patients attended to IBD clinic at Tropical Department
Who cannot join
- Age: less than 18 years
- Unstable patients or need for ICU admission
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Spectrum Of Airway Involvement In Inflammatory Bowel Disease
To estimate prevalence of subclinical airway injuries among IBD patients. To investigate relationship between activity of IBD and airways
Read the 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.
- Conditions
- IBD
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictors of airway diseases in patients with IBD
FROM risk factors
Measured: baseline
Secondary outcomes (1)
-Prevalence of of subclinical airway injuries among IBD patients presented to Tropical Department in Assiut University Hospital
from statistical anyalasis
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start20 Nov 2023 (estimated)
- Primary completion20 Nov 2024 (estimated)
- Study completion25 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for IBDStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Mohamed Sayed Mohamed, Assiut University
- Investigators
- Marwa Salama, MD, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090045
- Sponsor's protocol ID
- IBD&Airway
- Status last verified
- Oct 2023
- First submitted
- 13 Oct 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27678355Byrd 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.
PubMed 33679761
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectrum Of Airway Involvement In Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT06090045
- Acronym / sponsor ID
- IBD&Airway
- Conditions
- IBD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Nov 2023 (estimated)
- Primary completion
- 20 Nov 2024 (estimated)
- Study completion
- 25 Dec 2024 (estimated)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To estimate prevalence of subclinical airway injuries among IBD patients. To investigate relationship between activity of IBD and airways
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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:
Key inclusion criteria (1 listed)
- Patients attended to IBD clinic at Tropical Department
Key exclusion criteria (2 listed)
- Age: less than 18 years
- Unstable patients or need for ICU admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictors of airway diseases in patients with IBD
Time frame: baseline
FROM risk factors
1 secondary outcome
-Prevalence of of subclinical airway injuries among IBD patients presented to Tropical Department in Assiut University Hospital
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Background: PubMed 27678355Vutcovici 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.
- Background: PubMed 33679761Byrd 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwa Salama, MD study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of IBD, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hend Saleh, MD (01098987812, hend.m.saleh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictors of airway diseases in patients with IBD (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06090045, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.