Vonoprazan-based Triple Therapy vs. Standard Triple Therapy for Helicobacter Pylori Eradication in Adolescents: A Randomized, Double-blinded Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- Helicobacter Pylori eradication rate
研究概览
简要总结
The trial tends to evaluate the efficacy of vonoprazan-based triple therapy in eradicating H. Pylori infection in adolescent patients in Egypt, in comparison to standard treatment regimens to determine if it offers superior eradication rates (VONTAPE trial).
详细描述
The VONTAPE trial will compare two treatment regimens for Helicobacter pylori eradication among adolescent patients presented to the gastroenterology department in an Egyptian institute. the eligible subjects will be randomly assigned to one of the two protocols (vonoprazan based vs. proton pump inhibitor-based triple therapy) for two weeks. then the eradication rates will be compared between the two study groups to see if there is a difference in efficacy.
The currently available eradication regimens in our country show a low to intermediate eradication rate (50-75%). At the same time, H. pylori infection is prevalent.
Recently, the FDA approved vonoprazan-based regimens for adult H. pylori infection with high eradication rates even in the settings of clarithromycin antibiotic resistance.
In the VOTSAPE trial, we will test this efficacy in the < 18 years adolescents.
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
- Double (Participant, Investigator)
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
- •Children in the age group (10-18 years), both genders, referred with dyspeptic complaints such as heartburn, dyspepsia, nausea, and epigastric pain.
- •Who is 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.
- •Use of antibiotics, acid-suppression, bismuth, or probiotics 4 weeks before enrollment.
- •Children with conditions that affect medication absorption e.g. celiac or Crohn's disease.
- •Liver or kidney failure.
- •symptoms suggestive of functional disorders.
研究组 & 干预措施
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)
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)
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)
Proton pump-based triple therapy "standard triple therapy"
Esomeprazole tablets [20 mg/day if < 30 kg and 40 mg/daily if ≥ 30 kg] on two divided daily doses 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)
Proton pump-based triple therapy "standard triple therapy"
Esomeprazole tablets [20 mg/day if < 30 kg and 40 mg/daily if ≥ 30 kg] on two divided daily doses 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)
Proton pump-based triple therapy "standard triple therapy"
Esomeprazole tablets [20 mg/day if < 30 kg and 40 mg/daily if ≥ 30 kg] on two divided daily doses 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: Esomeprazole (Drug)
结局指标
主要结局
Helicobacter Pylori eradication rate
时间窗: 4 weeks after completion of treatment
Number of patients who will test negative for H. pylori after treatment completion.
次要结局
- The adverse events during therapy(During the treatment duration, and the end of the 2 weeks treatment protocol)
研究者
Sameh A. Lashen
Assistant Professor
Alexandria University