Efficacy of susceptibility-guided quadruple therapy with antibiotic resistance using the string test coupled with quantitative PCR for Helicobacter pylori eradication: a protocol of a multicentre, open, randomised clinical trial
Introduction Helicobacter pylori is a major health problem, with the high prevalence of H. pylori and the increasing antibiotic resistance rate in China. Antibiotic resistance is the main reason for the failure of H. pylori eradication. This study aims to evaluate the efficacy and safety of suscepti...
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BMJ Publishing Group
2024-12-01
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| author | Geliang Yang Yi Cui Shenke Zhang Shuqin Hu Sujuan Fei |
| author_facet | Geliang Yang Yi Cui Shenke Zhang Shuqin Hu Sujuan Fei |
| author_sort | Geliang Yang |
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| description | Introduction Helicobacter pylori is a major health problem, with the high prevalence of H. pylori and the increasing antibiotic resistance rate in China. Antibiotic resistance is the main reason for the failure of H. pylori eradication. This study aims to evaluate the efficacy and safety of susceptibility-guided quadruple therapy with antibiotic resistance using the string test coupled with quantitative PCR (qPCR) for H. pylori eradication.Methods and analysis This is a multicentre, open, randomised clinical trial that will enroll 324 patients with H. pylori infection. Patients will be randomised to two groups for a 14-day treatment: Treatment group will be treated with proton pump inhibitor (PPI), bismuth with two different kinds of antibiotics susceptibly guided by string test coupled with qPCR, while control group will be treated empirically with PPI, bismuth with two different kinds of antibiotics. The types and dosages of bismuth, PPI and antibiotics administered in this trial are based on the 2022 Chinese Guidelines for the treatment of H. pylori infection and the Sixth Chinese National Consensus Report on the management of H. pylori infection. The primary endpoint is the eradication rate, while secondary endpoints include compliance, the incidence of adverse events and adverse drug reactions.Ethics and dissemination This study was approved by the ethics committee of the Third People’s Hospital of Zhengzhou (No. 2024-04-001-K02). The results will be published in the appropriate peer-reviewed journal.Trial registration number ChiCTR2400082768. |
| format | Article |
| id | doaj-art-a726dcdfd9d54c538b827b806ae99183 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-a726dcdfd9d54c538b827b806ae991832025-01-14T11:40:11ZengBMJ Publishing GroupBMJ Open2044-60552024-12-01141210.1136/bmjopen-2024-088788Efficacy of susceptibility-guided quadruple therapy with antibiotic resistance using the string test coupled with quantitative PCR for Helicobacter pylori eradication: a protocol of a multicentre, open, randomised clinical trialGeliang Yang0Yi Cui1Shenke Zhang2Shuqin Hu3Sujuan Fei43 Department of Medicine, Shanghai Clinical Research Center, Shanghai, China1 Department of Gastroenterology, The Third People`s Hospital of Zhengzhou, Zhengzhou, Henan, China2 Marshall Laboratory of Biomedical Engineering, School of Biomedical Engineering, Shenzhen University Medical School, Shenzhen University, Shenzhen, Guangdong, China3 Department of Medicine, Shanghai Clinical Research Center, Shanghai, China4 Department of Gastroenterology, Xuzhou Medical University Affiliated Hospital, Xuzhou, Jiangsu, ChinaIntroduction Helicobacter pylori is a major health problem, with the high prevalence of H. pylori and the increasing antibiotic resistance rate in China. Antibiotic resistance is the main reason for the failure of H. pylori eradication. This study aims to evaluate the efficacy and safety of susceptibility-guided quadruple therapy with antibiotic resistance using the string test coupled with quantitative PCR (qPCR) for H. pylori eradication.Methods and analysis This is a multicentre, open, randomised clinical trial that will enroll 324 patients with H. pylori infection. Patients will be randomised to two groups for a 14-day treatment: Treatment group will be treated with proton pump inhibitor (PPI), bismuth with two different kinds of antibiotics susceptibly guided by string test coupled with qPCR, while control group will be treated empirically with PPI, bismuth with two different kinds of antibiotics. The types and dosages of bismuth, PPI and antibiotics administered in this trial are based on the 2022 Chinese Guidelines for the treatment of H. pylori infection and the Sixth Chinese National Consensus Report on the management of H. pylori infection. The primary endpoint is the eradication rate, while secondary endpoints include compliance, the incidence of adverse events and adverse drug reactions.Ethics and dissemination This study was approved by the ethics committee of the Third People’s Hospital of Zhengzhou (No. 2024-04-001-K02). The results will be published in the appropriate peer-reviewed journal.Trial registration number ChiCTR2400082768.https://bmjopen.bmj.com/content/14/12/e088788.full |
| spellingShingle | Geliang Yang Yi Cui Shenke Zhang Shuqin Hu Sujuan Fei Efficacy of susceptibility-guided quadruple therapy with antibiotic resistance using the string test coupled with quantitative PCR for Helicobacter pylori eradication: a protocol of a multicentre, open, randomised clinical trial BMJ Open |
| title | Efficacy of susceptibility-guided quadruple therapy with antibiotic resistance using the string test coupled with quantitative PCR for Helicobacter pylori eradication: a protocol of a multicentre, open, randomised clinical trial |
| title_full | Efficacy of susceptibility-guided quadruple therapy with antibiotic resistance using the string test coupled with quantitative PCR for Helicobacter pylori eradication: a protocol of a multicentre, open, randomised clinical trial |
| title_fullStr | Efficacy of susceptibility-guided quadruple therapy with antibiotic resistance using the string test coupled with quantitative PCR for Helicobacter pylori eradication: a protocol of a multicentre, open, randomised clinical trial |
| title_full_unstemmed | Efficacy of susceptibility-guided quadruple therapy with antibiotic resistance using the string test coupled with quantitative PCR for Helicobacter pylori eradication: a protocol of a multicentre, open, randomised clinical trial |
| title_short | Efficacy of susceptibility-guided quadruple therapy with antibiotic resistance using the string test coupled with quantitative PCR for Helicobacter pylori eradication: a protocol of a multicentre, open, randomised clinical trial |
| title_sort | efficacy of susceptibility guided quadruple therapy with antibiotic resistance using the string test coupled with quantitative pcr for helicobacter pylori eradication a protocol of a multicentre open randomised clinical trial |
| url | https://bmjopen.bmj.com/content/14/12/e088788.full |
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