NCT07574879 Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
| NCT ID | NCT07574879 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Zagazig University |
| Condition | Chronic Obstructive Pulmonary Disease (COPD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 54 participants in total. It began in 2026-03-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Hanaa A Nofal, MD
STUDY DIRECTOR
Faculty of Medicine, Zagazig University
Frequently Asked Questions
Who can join the NCT07574879 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Chronic Obstructive Pulmonary Disease (COPD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07574879 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07574879 currently recruiting?
Yes, NCT07574879 is actively recruiting participants. Contact the research team at hanofal@medicine.zu.edu.eg for enrollment information.
Where is the NCT07574879 trial being conducted?
This trial is being conducted at Zagazig, Egypt.
Who is sponsoring the NCT07574879 clinical trial?
NCT07574879 is sponsored by Zagazig University. The principal investigator is Hanaa A Nofal, MD at Faculty of Medicine, Zagazig University. The trial plans to enroll 54 participants.
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