7-day Versus 14-day Vonoprazan-based Triple Therapy for Eradication of H. Pylori in Adolescents: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 326
- 试验地点
- 1
- 主要终点
- H. Pylori eradication rate
研究概览
简要总结
The study aims to test the efficacy of 7 days vs. 14 days of Vonoprazan-triple therapy in the eradication of Helicobacter Pylori infection in adolescents and young children.
详细描述
After being informed about the study details, all eligible participants (or their legal guardians) will give informed written consent to be involved. After a one week screening, eligible participants will be randomized to Vonoprazan plus Amoxicillin plus Clarithromycin triple therapy for either 14 days (group 1), or 7 days (group 2) at a 1:1 ratio. After the end of therapy, H. Pylori eradication will be evaluated after 4 weeks.
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
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants in the age group (10-18 years), both genders, referred with dyspeptic complaints such as heartburn, dyspepsia, nausea, and epigastric pain who are positive for H. Pylori infection by a standardized diagnostic test.
- •Pediatric patients with a clinical, laboratory, and endoscopic diagnosis of H.P.-positive gastritis and the other conditions necessary for H.P. eradication, according to the Maastricht V consensus report .
排除标准
- •allergy to any of the drugs used in the study
- •previous attempts to eradicate H.P.
- •receipt of antibiotics, PPIs, bismuth, H2 antagonists or probiotics within 4 weeks of the study.
- •Children with the diagnosis of any condition that might affect the absorption of drugs such as celiac disease or Crohn's disease.
- •hepatic impairment or kidney failure.
- •symptoms suggestive of functional disorders.
研究组 & 干预措施
7-days Vonoprazan-based triple therapy
Vonoprazan tablets 20 mg twice daily plus Amoxicillin 50 mg/kg/day capsules or suspension [maximum daily dose 2 g] plus Clarithromycin 20 mg/kg/day tablets or suspension [maximum daily dose 1 g]. The triple combination will be given for 7 days.
干预措施: Clarithromycin (Drug)
14-days Vonoprazan-based triple therapy
Vonoprazan tablets 20 mg twice daily plus Amoxicillin 50 mg/kg/day capsules or suspension [maximum daily dose 2 g] plus Clarithromycin 20 mg/kg/day tablets or suspension [maximum daily dose 1 g]. The triple combination will be given for 14 days .
干预措施: Vonoprazan (Drug)
14-days Vonoprazan-based triple therapy
Vonoprazan tablets 20 mg twice daily plus Amoxicillin 50 mg/kg/day capsules or suspension [maximum daily dose 2 g] plus Clarithromycin 20 mg/kg/day tablets or suspension [maximum daily dose 1 g]. The triple combination will be given for 14 days .
干预措施: Amoxicillin (Drug)
14-days Vonoprazan-based triple therapy
Vonoprazan tablets 20 mg twice daily plus Amoxicillin 50 mg/kg/day capsules or suspension [maximum daily dose 2 g] plus Clarithromycin 20 mg/kg/day tablets or suspension [maximum daily dose 1 g]. The triple combination will be given for 14 days .
干预措施: Clarithromycin (Drug)
7-days Vonoprazan-based triple therapy
Vonoprazan tablets 20 mg twice daily plus Amoxicillin 50 mg/kg/day capsules or suspension [maximum daily dose 2 g] plus Clarithromycin 20 mg/kg/day tablets or suspension [maximum daily dose 1 g]. The triple combination will be given for 7 days.
干预措施: Vonoprazan (Drug)
7-days Vonoprazan-based triple therapy
Vonoprazan tablets 20 mg twice daily plus Amoxicillin 50 mg/kg/day capsules or suspension [maximum daily dose 2 g] plus Clarithromycin 20 mg/kg/day tablets or suspension [maximum daily dose 1 g]. The triple combination will be given for 7 days.
干预措施: Amoxicillin (Drug)
结局指标
主要结局
H. Pylori eradication rate
时间窗: 4 weeks after completion of treatment
Number of participants who will achieve a negative H. pylori antigen detection test after the end of therapy.
次要结局
- Adverse events during treatment.(From first dose of treatment until 7 or 14 days of treatment regimen assigned.)
研究者
Sameh A. Lashen
Assistant Professor
Alexandria University