NCT07405684尚未招募4 期
Clinical Efficacy and Health Economic Evaluation of Fecal Molecular Susceptibility-guided Therapy for Helicobacter Pylori Infection First-line Treatment: Multicenter Randomized Controlled Study
Shanghai Zhongshan Hospital4 个研究点 分布在 1 个国家目标入组 544 人开始时间: 2026年2月28日最近更新:
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 544
- 试验地点
- 4
- 主要终点
- Eradication rate of Helicobacter pylori
研究概览
简要总结
The goal of this clinical trial is to evaluate the eradication efficacy and health economic benefits of individualized regimens guided by fecal molecular susceptibility testing with 7-day and 14-day courses in the first-line treatment of Helicobacter pylori infection. The main questions it aims to answer are:
- What is the H. pylori eradication rate of the 7-day versus 14-day individualized regimens?
- What are the safety, adherence, and cost-effectiveness of the 7-day versus 14-day individualized regimens? Researchers will compare the 7-day course group and the 14-day course group to see if the 7-day course is non-inferior to the 14-day course in terms of eradication rate.
Participants will:
- Undergo fecal H. pylori drug resistance gene testing
- Receive randomized assignment to either 7-day or 14-day individualized treatment based on drug susceptibility results
- Complete follow-up visits at 1 week and 4-8 weeks after stopping treatment for adverse event monitoring and 13C-urea breath test
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate in this clinical study; fully understand, be informed about this study, and sign the Informed Consent Form (ICF).
- •Age between 18 and 75 years (inclusive) on the day of signing the ICF.
- •13C-urea breath test (13C-UBT) and fecal HP nucleic acid detection confirming Helicobacter pylori (Hp) infection.
- •Not previously eradicated HP
排除标准
- •Individuals with a known allergy to the medication.
- •Patients with severe cardiovascular, pulmonary, renal, hepatic, hematologic, neurologic, endocrine, or psychiatric disorders;
- •Participants or guardians who refuse to enroll;
- •Alcohol and/or drug abuse (dependence or addiction) or individuals judged by the physician to have poor compliance; 5) Use of antibiotics, bismuth-containing drugs, PPIs, or traditional Chinese medicines within 4 weeks before treatment; 6) Pregnant or lactating women; 7) Any condition deemed by the investigator to be unsuitable for enrollment.
研究组 & 干预措施
7-day
Experimental
干预措施: 7-day fecal molecular susceptibility-guided therapy (Drug)
14-day
Active Comparator
干预措施: 14-day fecal molecular susceptibility-guided therapy (Drug)
结局指标
主要结局
Eradication rate of Helicobacter pylori
时间窗: 4-8 weeks after treatment
Eradication of Helicobacter pylori was defined as negative result of urea breath test (\<4‰ cut-off value)
次要结局
- Frequency of adverse events(Throughout the treatment period, up to 2 weeks)
- Adherence rate(Throughout the treatment period, up to 2 weeks)
研究者
研究点 (4)
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