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Clinical Trials in Egypt / NCT07574879
Recruiting Phase 1

Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:

NCT07574879 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 1
Started
2026-03-01
Last updated
2026-05-08

Condition(s) studied

Chronic Obstructive Pulmonary Disease (COPD)With Poitive H Pylori

Investigational drug(s) / intervention(s)

Eradication of Helcobacter Pylori

Eradication of Helcobacter Pylori: Pre- intervention stage:Perform baseline spirometry and laboratory markers, Assess severity of COPD according to GOLD criteria: stage 1 (FEV1 ≥80%), stage 2 (50% ≤FEV1 \<80%), stage 3 (30% ≤FEV1 \<50%), and stage 4 (FEV1 \<30%). * Intervention stage: For H. pylori-positive COPD patients: administer standard eradication therapy according to current guidelines (e.g., triple or quadruple therapy with proton pump inhibitor and antibiotics). Confirm eradication at least 4-6 weeks after therapy completion via repeat testing. * Post intervention: Reassess COPD symptoms, lung function, and biomarkers 3 months after successful H. pylori eradication. Follow up H. Pylori-positive COPD patients for 3months by reassessment of COPD symptoms, lung function and biomarkers.

Study summary

Helicobacter pylori (HP) is a well-established pathogen responsible for chronic gastritis and peptic ulcer disease. Its presence has been implicated in the development of gastric malignancies such as adenocarcinoma and mucosa-associated lymphoid tissue lymphoma. Chronic H. pylori infection is associated with systemic inflammatory responses and various extra gastric diseases, including cardiovascular, metabolic, and neurological disorders. Furthermore, H. pylori infection contributes to gastrointestinal dysbiosis by interacting with gastrointestinal microbiota, which may be involved in gastric carcinogenesis and other systemic disorders. Growing evidence highlights the role of dysbiosis in chronic respiratory diseases, such as chronic obstructive pulmonary disease (COPD) and asthma. Emerging epidemiological evidence suggests a potential association between H. pylori infection and respiratory diseases, including COPD. Several observational studies and meta-analyses have found that H. pylori infection in patients with COPD may be associated with systemic inflammatory markers and altered pulmonary function parameters. Despite these associations, the causal mechanisms underlying this relationship remain unclear. Furthermore, it is uncertain whether eradication of H. pylori yields measurable benefits on clinical outcomes in COPD patients. So, Our aim to evaluate changes in symptoms, pulmonary function, and inflammatory markers after H. pylori eradication therapy in the H. pylori-positive COPD patients.

an intervention study (quasi experimental), study will be carried out in the inpatient and outpatient clinics of Chest Department, Faculty of Medicine, Zagazig University hospitals.

Patients included in the study:

well controlled COPD patients attending outpatient clinics for a period of 6 months fulfilling inclusion and exclusion criteria will be included in this study.

Eligibility

Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adults aged ≥40 years. * Diagnosed with COPD confirmed by spirometry (post-bronchodilator FEV1/FVC \< 0.70) and H. pylori positive. * Willing to participate and provide consent for testing and follow-up. Exclusion Criteria: * patients with asthma, known peptic ulcers, acute exacerbation of COPD * patients who took antibiotics and PPIs within the last month, * Patients who took histamine-2-receptor antagonists within the last week or antacid within the last 24 hours a * those having H. pylori eradication treatment within the last 6 months

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Zagazig University outpatients clinics Zagazig Elsharkia Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07574879 on ClinicalTrials.gov ↗ ← All trials in Egypt