Eradicating Helicobacter pylori in adults with COPD
Impact of Eradication Therapy on Helicobacter Pylori Infection in Patients With Chronic Obstructive Pulmonary Disease: A Prospective Study
This project will try whether getting rid of H. pylori helps adults with COPD have fewer respiratory problems or less inflammation.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Zagazig University Government |
| Locations | 1 site (Zagazig, Elsharkia) |
| Trial ID | NCT07574879 on ClinicalTrials.gov |
What this trial studies
This is a quasi-experimental interventional study at Zagazig University recruiting consecutive, well‑controlled COPD patients over six months and screening them for H. pylori using a stool antigen lateral flow test. Patients aged 40 and older who are spirometry‑confirmed COPD and H. pylori positive will receive standard eradication therapy and be followed in the outpatient and inpatient chest clinics. Baseline data including spirometry, smoking history, comorbidities, and prior exacerbations will be collected and outcomes will include exacerbation and hospitalization rates and markers of systemic inflammation. About 108 COPD patients are expected to be screened to enroll roughly 54 H. pylori‑positive participants.
Who should consider this trial
Good fit: Adults 40 years or older with spirometry‑confirmed, well‑controlled COPD who test positive for H. pylori and can provide informed consent are ideal candidates.
Not a fit: Patients without H. pylori, those with asthma, active peptic ulcer disease, recent antibiotics/PPIs or recent H. pylori treatment, or those in acute COPD exacerbation are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, eradication of H. pylori could reduce COPD exacerbations and systemic inflammation, improving breathing and quality of life.
How similar studies have performed: Observational studies and meta-analyses have reported associations between H. pylori and respiratory disease, but randomized or interventional evidence specifically testing eradication in COPD is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Zagazig, Elsharkia
- Zagazig University outpatients clinics — Zagazig, Elsharkia, Egypt (Recruiting)
Study contacts
- Study coordinator: Hanaa A Nofal, MD
- Email: hanofal@medicine.zu.edu.eg
- Phone: 01006806873
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.