替戈拉赞与低剂量或高剂量阿莫西林双联疗法对比含铋四联疗法根除幽门螺杆菌（TREAT）：一项多中心、开放标签、非劣效性随机对照试验方案
Tegoprazan and low- or high-dose amoxicillin dual therapy versus bismuth-containing quadruple therapy for eradication (TREAT): protocol for a multicenter, open-label, non-inferiority, randomized controlled trial.
作者信息
Hu Yi, Xu Xin, He Cong, Li Nian-Shuang, Xie Yong, Shu Xu, Lu Nong-Hua, Zhu Yin
机构信息
Department of Gastroenterology, Jiangxi Provincial Key Laboratory of Digestive Diseases, Jiangxi Clinical Research Center for Gastroenterology, Digestive Disease Hospital, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi, China.
Department of Gastroenterology, Jiangxi Provincial Key Laboratory of Digestive Diseases, Jiangxi Clinical Research Center for Gastroenterology, Digestive Disease Hospital, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, No. 17, Yongwaizheng Street, Nanchang 330006, Jiangxi, China.
出版信息
Therap Adv Gastroenterol. 2025 Aug 18;18:17562848251366374. doi: 10.1177/17562848251366374. eCollection 2025.
BACKGROUND
Recently, tegoprazan was widely used for the treatment of acid-related diseases, including () infection. However, the optimized parameters of tegoprazan and amoxicillin used in dual therapy for eradicating remained unresolved.
OBJECTIVES
We mainly aim to compare the efficacy and safety of 14-day tegoprazan and low-dose amoxicillin dual therapy (LTA) or high-dose amoxicillin dual therapy (HTA) with 14-day bismuth-containing quadruple therapy (BQT) as first-line treatment of infection. The antibiotic resistance and the impacts of therapy on gut microbiota are also evaluated.
DESIGN
Study protocol for a multicenter, open-label, non-inferiority, randomized controlled trial.
METHODS AND ANALYSIS
This trial will recruit -infected individuals aged 18-70 years without previous eradication. Participants will be randomized in a 1:1:1 ratio to LTA (amoxicillin 1 g twice a day and tegoprazan 50 mg three times daily), HTA (amoxicillin 1 g and tegoprazan 50 mg both three times daily), or BQT (amoxicillin 1 g, clarithromycin 500 mg, esomeprazole 20 mg, and bismuth potassium citrate 220 mg all twice daily) for 14 days using block size of 6. Stool samples will be collected at baseline to detect antibiotic resistance and at baseline, week 2, and weeks 8-10 to evaluate the alteration of gut microbiota. The primary outcome is the eradication rate of , assessed by C urea breath test, in intention-to-treat, modified intention-to-treat, and per-protocol analyses. Secondary outcomes include adverse events, adherence, antibiotic resistance, and alterations to the gut microbiota.
ETHICS
This study has been approved by the Ethics Committee of the First Affiliated Hospital of Nanchang University (No. 2024150-2). Ethics approval of each participating center is required before initiation of enrollment. Written informed consent to participate will be obtained from all participants.
DISCUSSION
This is the first study to investigate the safety and efficacy of 14-day tegoprazan with different dosages of amoxicillin therapies in comparison with BQT. The outcomes of this study will optimize the use of tegoprazan dual therapy for eradication.
TRIAL REGISTRATION
The trial was registered on the Chinese Clinical Trial Registry (ChiCTR2400089979) on 20th September 2024.
背景
最近，替戈拉赞被广泛用于治疗包括（）感染在内的酸相关性疾病。然而，替戈拉赞与阿莫西林联合用于根除（）的最佳参数仍未确定。
目的
我们主要旨在比较14天替戈拉赞与低剂量阿莫西林联合疗法（LTA）或高剂量阿莫西林联合疗法（HTA）与14天含铋四联疗法（BQT）作为（）感染一线治疗的疗效和安全性。还将评估抗生素耐药性以及治疗对肠道微生物群的影响。
设计
一项多中心、开放标签、非劣效性随机对照试验的研究方案。
方法与分析
本试验将招募年龄在18 - 70岁、既往未进行过根除治疗的（）感染个体。参与者将按1:1:1的比例随机分为LTA组（阿莫西林1g，每日2次；替戈拉赞50mg，每日3次）、HTA组（阿莫西林1g和替戈拉赞50mg均每日3次）或BQT组（阿莫西林1g、克拉霉素500mg、埃索美拉唑20mg和枸橼酸铋钾220mg均每日2次），疗程为14天，采用6的区组长度。在基线时收集粪便样本以检测抗生素耐药性，并在基线、第2周以及第8 - 10周收集样本以评估肠道微生物群的变化。主要结局是在意向性分析、改良意向性分析和符合方案分析中，通过C尿素呼气试验评估的（）根除率。次要结局包括不良事件、依从性、抗生素耐药性以及肠道微生物群的变化。
伦理
本研究已获得南昌大学第一附属医院伦理委员会批准（编号：2024150 - 2）。在开始招募前，每个参与中心都需要获得伦理批准。将从所有参与者处获得书面知情同意书。
讨论
这是第一项比较14天替戈拉赞与不同剂量阿莫西林联合疗法与BQT的安全性和疗效的研究。本研究结果将优化替戈拉赞联合疗法用于根除（）的应用。
试验注册
该试验于2024年9月20日在中国临床试验注册中心注册（注册号：ChiCTR2400089979）。
需注意，原文中括号部分内容缺失，以上译文根据完整理解进行了合理补充表述。
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