A Single-Center, Single-Arm Clinical Trial to Evaluate the Efficacy of Probit-Based Triple Therapy for Helicobacter Pylori Eradication
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 103
- 主要终点
- Eradication rate
研究概览
简要总结
This is a single-center, open-label, non-randomized, single-arm clinical study. Eligible participants who provide written informed consent will undergo screening based on inclusion/exclusion criteria. Enrolled subjects will receive the investigational treatment: Zastaprazan 20 mg (twice daily), clarithromycin 500 mg (twice daily), and amoxicillin 1000 mg (three times daily) for 14 days. Four to eight weeks after completing the therapy, participants will return for a urea breath test to assess H. pylori eradication. The study will also investigate the efficacy of this therapy in clarithromycin-resistant patients to indirectly assess the potential of a dual regimen using Zastaprazan and amoxicillin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 19 to 75 years at consent.
- •Confirmed H. pylori positive by urease breath or enzyme test.
- •Require eradication therapy due to at least one condition: chronic atrophic gastritis, peptic ulcer, history of early gastric cancer or adenoma resection, functional dyspepsia, low-grade MALT lymphoma, idiopathic thrombocytopenic purpura, iron deficiency anemia, hyperplastic polyps, or family history of gastric cancer.
- •Agree to use medically acceptable contraception during the trial (including medically sterile women such as menopausal, hysterectomy, tubal ligation, or bilateral oophorectomy).
- •Provide voluntary written informed consent.
排除标准
- •History of receiving H. pylori eradication therapy prior to study participation.
- •Known hypersensitivity to the investigational product, penicillin-class antibiotics, or macrolide-class antibiotics.
- •Current use of medications contraindicated with the investigational product or concomitant therapy.
- •Abnormal laboratory values in blood chemistry tests as defined by the protocol.
- •pregnant or nursing women
研究组 & 干预措施
This study aims to evaluate the efficacy and safety of a 14-day triple therapy regimen consisting of
干预措施: This study aims to evaluate the efficacy and safety of a 14-day triple therapy regimen consisting of Zastaprazan 20 mg, clarithromycin, and amoxicillin for the eradication of Helicobacter pylori. (Drug)
结局指标
主要结局
Eradication rate
时间窗: 4 to 8 weeks
Efficacy of H. pylori eradication therapy. confirmed by negative UBT test
次要结局
未报告次要终点