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

Impact of Eradication Therapy on Helicobacter Pylori Infection in Patients With Chronic Obstructive Pulmonary Disease: A Prospective Study

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease (COPD); With Poitive H Pylori
• Intervention / Treatment: Drug: Eradication of Helcobacter Pylori

Detailed Description

An interventional study (quasi experimental), this 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.

• Sample size and selection:

All patients diagnosed with COPD attending the study setting during the specified study period (6 months) will be consecutively screened for Helicobacter pylori infection.

All eligible patients who test positive for H. pylori will be included in the intervention phase and will receive eradication therapy.

Therefore, a consecutive sampling technique will be applied, all available cases during the study period will be recruited. Based on the expected patient flow, approximately 108 COPD patients are anticipated over 6 months, with an estimated H. pylori prevalence of around 50% ((Abdelmagied etal., 2019), yielding about 54 cases for the intervention phase.

All patients will be subjected to the following:

1. Recruitment of COPD patients based on clinical diagnosis and spirometry.
2. Collection of baseline demographics, smoking history, comorbidities, exacerbation and hospitalization rate in past year.
3. Assess H. pylori status using Stool antigen test for H. pylori by using rapid antigen test (lateral flow immune chromatographic test with a monoclonal antibody). It has a positive line to indicate a positive reading accompanied by a control line. The test has been reported sensitivity and specificity (94% and 98% respectively.
4. Perform 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.
5. Perform baseline spirometry and laboratory markers.
6. 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%).
7. 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.
8. Reassess COPD symptoms, lung function, and biomarkers 3months after successful H. pylori eradication.
9. Follow up H. Pylori-positive COPD patients for 3months by reassessment of COPD symptoms, lung function and biomarkers.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Hanaa A Nofal, MD; Phone Number: 01006806873; Email: hanofal@medicine.zu.edu.eg
• Study Contact Backup: Name: Maha Elsayed Alsadik, MD; Phone Number: 01127123248

Study Locations

• Egypt
  • Elsharkia
    • Zagazig, Elsharkia, Egypt, 44
      • Recruiting
      • Zagazig University outpatients clinics
      • Contact: Hanaa A Nofal, MD; Phone Number: 01006806873; Email: hanofal@medicine.zu.edu.eg
      • Contact: Maha Elsayed Alsadik, MD; Phone Number: 01127123248
      • Principal Investigator: Maha Elsayed Alsadik, MD
      • Principal Investigator: Enaam Mohammed Ismail ElSayed, MD
      • Sub-Investigator: Hanaa A Nofal, MD
      • Sub-Investigator: Ahmed Attia Abdelmoaty, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention group; 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).

Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FEV₁ - Volume exhaled in first second	FEV₁ - Volume exhaled in first second; Unit: L	3 months after treatment
FVC - Total forced exhaled volume; Unit: L	FVC - Total forced exhaled volume; Unit: L	3 months after treatment
FEV₁/FVC Ratio - Airflow limitation index; Unit: %	FEV₁/FVC Ratio - Airflow limitation index; Unit: %	3 months after treatment
CRP - Systemic inflammation marker; Unit: mg/L	CRP - Systemic inflammation marker; Unit: mg/L	3 months after treatment
PaO₂ - Arterial oxygen pressure; Unit: mmHg	PaO₂ - Arterial oxygen pressure; Unit: mmHg	3 months after treatment
PaCO₂ - Arterial carbon dioxide pressure; Unit: mmHg	PaCO₂ - Arterial carbon dioxide pressure; Unit: mmHg	3 months after treatment
pH - Arterial acid base status	pH - Arterial acid base status	3 months after treatment

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Study Director: Hanaa A Nofal, MD, Faculty of Medicine, Zagazig University

Publications and helpful links

General Publications

• 1. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for prevention, diagnosis and management of COPD: 2025 Report. Available on: goldcopd.org/. 2. World Health Organization. Chronic obstructive pulmonary disease (COPD). Available on: www.who.int/news-room/fact -sheets/detail/chronic-obstructive-pulmonary-disease-(copd). 3. Malfertheiner P, Camargo MC, El-Omar E, Liou JM, Peek R, Schulz C, et al. Helicobacter pylori infection. Nat Rev Dis Primers. 2023;9:19. 4. Shin DW, Kwon HT, Kang JM, Park JH, Choi HC, Park MS, et al. Association between metabolic syndrome and Helicobacter pylori infection diagnosed by histologic status and serological status. J Clin Gastroenterol. 2012;46:840-5. 5. Bakhti SZ, Latifi-Navid S. Interplay and cooperation of Helicobacter pylori and gut microbiota in gastric carcinogenesis. BMC Microbiol. 2021;21:258. 6. Hou K, Wu ZX, Chen XY, Wang JQ, Zhang D, Xiao C, et al. Microbiota in health and diseases. Signal Transduct Target Ther. 2022;7:135. 7. Li N, Dai Z, Wang Z, Deng Z, Zhang J, Pu J, et al. Gut microbiota dysbiosis contributes to the development of chronic obstructive pulmonary disease. Respir Res. 2021;22:274. 8. Hufnagl K, Pali-Scholl I, Roth-Walter F, Jensen-Jarolim E. Dysbiosis of the gut and lung microbiome has a role in asthma. Semin Immunopathol. 2020;42:75-93. 9. González-Saitz A, Díez-Manglano J. Helicobacter pylori infection in patients with chronic obstructive pulmonary disease. A systematic review and meta-analysis. Rev Clin Esp (Barc). 2025 Apr;225(4):193-203. doi: 10.1016/j.rceng.2024.12.004. Epub 2025 Feb 7. 10. Alexandra J, Baumann., D.O. and Staros E: Helicobacter Pylori Antigen Test. e-medicine. medscape. com/ article/2117821-overview. 2014. 11. Jones PW, Harding G, Berry P, Wiklund I, Chen WH and Kline Leidy N: Development and first validation of the COPD Assessment Test. Eur Respir J.; 2009, 34(3):648-54. 12. Aumpan N, Mahachai V, Vilaichone RK. Management of Helicobacter pylor

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: May 3, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Helicobacter Pylori; eradication therapy; Chronic Obstructive Pulmonary disease
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: Helicobacter pylori infection

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to privacy of data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No