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

3 mei 2026 bijgewerkt door: Zagazig University

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

54

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

  • Naam: Maha Elsayed Alsadik, MD
  • Telefoonnummer: 01127123248

Studie Locaties

  • Egypte
    • Elsharkia
      • Zagazig, Elsharkia, Egypte, 44
        • Werving
        • Zagazig University outpatients clinics
        • Contact:
        • Contact:
          • Maha Elsayed Alsadik, MD
          • Telefoonnummer: 01127123248
        • Hoofdonderzoeker:
          • Maha Elsayed Alsadik, MD
        • Hoofdonderzoeker:
          • Enaam Mohammed Ismail ElSayed, MD
        • Onderonderzoeker:
          • Hanaa A Nofal, MD
        • Onderonderzoeker:
          • Ahmed Attia Abdelmoaty, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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).
Geneesmiddel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Primary outcome measures
Tijdsspanne: 3 months
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

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Zagazig University

Onderzoekers

  • Studie directeur: Hanaa A Nofal, MD, Faculty of medicine, Zagazig university

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

  • 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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 maart 2026

Primaire voltooiing (Geschat)

1 september 2026

Studie voltooiing (Geschat)

1 december 2026

Studieregistratiedata

Eerst ingediend

31 maart 2026

Eerst ingediend dat voldeed aan de QC-criteria

3 mei 2026

Eerst geplaatst (Werkelijk)

8 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

3 mei 2026

Laatst geverifieerd

1 maart 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Helicobacter pylori infection

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Due to privacy of data

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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