Comparison of Omeprazole vs Vonoprazon in Treatment of H Pylori Infection
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Clarithromycin 500 mg, Amoxicillin 1 g, Omeprazole 40 mg, Clarithromycin 500 mg.
- Кому может быть актуально
- Состояния в реестре: H Pylori. Базовые параметры: от 12 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Пакистан
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Comparative Efficacy of Omeprazole and Vonoprazan in the Treatment of Helicobacter Pylori Infection
Обзор
Current studies have primarily focused on comparing the advantages and disadvantages of P-CAB and PPI drugs, with little comparison between different P-CAB drugs or between regimens with varying drug combinations and treatment durations. This study aims to evaluate the clinical effectiveness of vonoprazan-based H. pylori eradication therapy and compare it to that of conventional PPI based therapy in clinical practice.
Подробное описание
Currently, there are numerous H. pylori eradication regimens, but opinions vary regarding the effectiveness of those based on P-CAB or PPI. Zhang et al. 4 concluded that the P-CAB-based triple regimen was superior to the PPI-based regimen, whereas Du et al.5 suggested that a vonoprazan and amoxicillin duo regimen may be the preferred first-line option for H. pylori eradication in clinical practice. However, due to limited evidence, the efficacy of various H. pylori eradication regimens using tegoprazan or vonoprazan could not be compared.
Current studies have primarily focused on comparing the advantages and disadvantages of P-CAB and PPI drugs, with little comparison between different P-CAB drugs or between regimens with varying drug combinations and treatment durations.
This study aims to evaluate the clinical effectiveness of vonoprazan-based H. pylori eradication therapy and compare it to that of conventional PPI based therapy in clinical practice.
Objective: To compare the efficacy of vonoprazan-based H. pylori eradication therapy with conventional proton pump inhibitors based therapy.
Вмешательства
- Препарат Clarithromycin 500 mg
Clarithromycin 500 mg orally twice daily for 14 days - Препарат Amoxicillin 1 g
Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks - Препарат Omeprazole 40 mg
Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks - Препарат Clarithromycin 500 mg
Clarithromycin 500 mg orally twice daily for 14 days - Препарат Amoxicillin 1 g
Amoxicillin 1 g orally twice daily for 14 days - Препарат Vonoprazan 20 mg
Vonoprazan 20 mg orally twice daily for 14 days, then 20 mg once daily for 4 weeks - Препарат Levofloxacin 500 mg
Levofloxacin 500 mg orally once daily for 14 days - Препарат Amoxicillin 1 g
Amoxicillin 1 g orally twice daily for 14 days - Препарат Omeprazole 40 mg
Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks - Препарат Levofloxacin 500 mg
Levofloxacin 500 mg orally once daily for 14 days
Первичные конечные точки
- H. pylori Eradication Rate [Срок оценки: 4-6 weeks after completion of therapy]
Вторичные конечные точки (1)
- Incidence of Adverse Events [Срок оценки: During the 6-week treatment and follow-up period]
Критерии участия
Критерии включения
- All patients who tested positive on stool antigen
Критерии исключения
- patients under 12 years old.
- Patients who have penicillin allergy.
- Patients who have underlying dysrhythmia forbidding the use of macrolide -. Patient who have hypersensitivity to any of these antibiotics or proton pump inhibitors.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Пакистан · 1 центр
- Rehman Medical Institue — Peshawar
Публикации
- Malfertheiner P, Moss SF, Daniele P, Pelletier C, Jacob R, Tremblay G, Hubscher E, Leifke E, Chey WD. Potassium-Competitive Acid Blocker and Proton Pump Inhibitor-Based Regimens for First-Line Helicobacter pylori Eradication: A Network Meta-Analysis. Gastro Hep Adv. 2022 Jun 17;1(5):824-834. doi: 10.1016/j.gastha.2022.06.009. eCollection 2022. PMID 39131848
- Du RC, Hu YX, Ouyang Y, Ling LX, Xu JY, Sa R, Liu XS, Hong JB, Zhu Y, Lu NH, Hu Y. Vonoprazan and amoxicillin dual therapy as the first-line treatment of Helicobacter pylori infection: A systematic review and meta-analysis. Helicobacter. 2024 Jan-Feb;29(1):e13039. doi: 10.1111/hel.13039. Epub 2023 Nov 30. PMID 38036941
- Zhang M, Pang M, Zhang M. Efficacy and safety of potassium-competitive acid blockers versus proton pump inhibitors as Helicobacter pylori eradication therapy: a meta-analysis of randomized clinical trials. Clinics (Sao Paulo). 2022 Jul 7;77:100058. doi: 10.1016/j.clinsp.2022.100058. eCollection 2022. PMID 35810638
- Kim GH. Proton Pump Inhibitor-Related Gastric Mucosal Changes. Gut Liver. 2021 Sep 15;15(5):646-652. doi: 10.5009/gnl20036. PMID 32327613
- Kiyotoki S, Nishikawa J, Sakaida I. Efficacy of Vonoprazan for Helicobacter pylori Eradication. Intern Med. 2020 Jan 15;59(2):153-161. doi: 10.2169/internalmedicine.2521-18. Epub 2019 Jun 27. PMID 31243237
- Sun Y, Zhang J. Helicobacter pylori recrudescence and its influencing factors. J Cell Mol Med. 2019 Dec;23(12):7919-7925. doi: 10.1111/jcmm.14682. Epub 2019 Sep 19. PMID 31536675
Идентификаторы
NCT: NCT07040839 · RMI/RMI-REC/approval 182