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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age40+
SponsorZagazig University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Eradication of Helcobacter Pylori

    Drug

    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.

Treatment groups

54 Participants
are divided into 1 treatment group
Group A: Intervention groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Primary outcome measures

Reassess symptoms of COPD by COPD Assessment Test (CAT): The COPD Assessment Test (CAT) is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this change over time. The CAT is a standard and validated test containing eight items for the evaluation of the impact of COPD on health status

Time frame
3 months

Secondary outcomes

1

FEV₁ - Volume exhaled in first second

FEV₁ - Volume exhaled in first second; Unit: L

Time frame
3 months after treatment
2

FVC - Total forced exhaled volume; Unit: L

FVC - Total forced exhaled volume; Unit: L

Time frame
3 months after treatment
3

FEV₁/FVC Ratio - Airflow limitation index; Unit: %

FEV₁/FVC Ratio - Airflow limitation index; Unit: %

Time frame
3 months after treatment
4

CRP - Systemic inflammation marker; Unit: mg/L

CRP - Systemic inflammation marker; Unit: mg/L

Time frame
3 months after treatment

Other outcomes

Sponsors and contacts

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