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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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:
- Recruitment of COPD patients based on clinical diagnosis and spirometry.
- Collection of baseline demographics, smoking history, comorbidities, exacerbation and hospitalization rate in past year.
- 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.
- 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.
- 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%).
- 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.
- Reassess COPD symptoms, lung function, and biomarkers 3months after successful H. pylori eradication.
- Follow up H. Pylori-positive COPD patients for 3months by reassessment of COPD symptoms, lung function and biomarkers.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 1
Kontakty a umístění
Studijní kontakt
- Jméno: Hanaa A Nofal, MD
- Telefonní číslo: 01006806873
- E-mail: hanofal@medicine.zu.edu.eg
Studijní záloha kontaktů
- Jméno: Maha Elsayed Alsadik, MD
- Telefonní číslo: 01127123248
Studijní místa
-
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Elsharkia
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Zagazig, Elsharkia, Egypt, 44
- Nábor
- Zagazig University outpatients clinics
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Kontakt:
- Hanaa A Nofal, MD
- Telefonní číslo: 01006806873
- E-mail: hanofal@medicine.zu.edu.eg
-
Kontakt:
- Maha Elsayed Alsadik, MD
- Telefonní číslo: 01127123248
-
Vrchní vyšetřovatel:
- Maha Elsayed Alsadik, MD
-
Vrchní vyšetřovatel:
- Enaam Mohammed Ismail ElSayed, MD
-
Dílčí vyšetřovatel:
- Hanaa A Nofal, MD
-
Dílčí vyšetřovatel:
- Ahmed Attia Abdelmoaty, MD
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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).
|
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%).
Follow up H. Pylori-positive COPD patients for 3months by reassessment of COPD symptoms, lung function and biomarkers. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Primary outcome measures
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
FEV₁ - Volume exhaled in first second
Časové okno: 3 months after treatment
|
FEV₁ - Volume exhaled in first second; Unit: L
|
3 months after treatment
|
|
FVC - Total forced exhaled volume; Unit: L
Časové okno: 3 months after treatment
|
FVC - Total forced exhaled volume; Unit: L
|
3 months after treatment
|
|
FEV₁/FVC Ratio - Airflow limitation index; Unit: %
Časové okno: 3 months after treatment
|
FEV₁/FVC Ratio - Airflow limitation index; Unit: %
|
3 months after treatment
|
|
CRP - Systemic inflammation marker; Unit: mg/L
Časové okno: 3 months after treatment
|
CRP - Systemic inflammation marker; Unit: mg/L
|
3 months after treatment
|
|
PaO₂ - Arterial oxygen pressure; Unit: mmHg
Časové okno: 3 months after treatment
|
PaO₂ - Arterial oxygen pressure; Unit: mmHg
|
3 months after treatment
|
|
PaCO₂ - Arterial carbon dioxide pressure; Unit: mmHg
Časové okno: 3 months after treatment
|
PaCO₂ - Arterial carbon dioxide pressure; Unit: mmHg
|
3 months after treatment
|
|
pH - Arterial acid base status
Časové okno: 3 months after treatment
|
pH - Arterial acid base status
|
3 months after treatment
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Hanaa A Nofal, MD, Faculty of Medicine, Zagazig University
Publikace a užitečné odkazy
Obecné publikace
- 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
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Helicobacter pylori infection
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
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