Tailored Therapy Versus Standard Triple Therapy for Helicobacter Pylori Eradication in Children: A Randomized Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 主要终点
- Compare the eradication rates in each group
研究概览
简要总结
This study is designed to compare the eradication rates，safety and compliance of tailored therapy to those of standard triple therapy in children with H. pylori infection. The primary purpose is to compare the eradication rates of children with H. pylori infection treated with tailored therapy to those treated with standard triple therapy. The secondary purpose is to evaluate the safety, compliance and factors that might affect eradication rates.
详细描述
Between March 2014 and March 2016, 200 children with upper gastrointestinal symptoms (4-18 years) and H. pylori infection will be recruited at Beijing Children Hospital.After the informed consents are obtained from the guardians, the children will be randomly classified into the two group: 10 days standard triple therapy (Omeprazole 0.8-1.0mg/kg.d,bid, Amoxicillin 30-50mg/kg.d bid， Clarithromycin 15-20mg/kg.d bid), or 10 days tailored therapy including one Proton Pump Inhibitor ( Rabeprazole 0.4-0.5mg/kg.d,bid. or Esomeprazole 0.8-1.0mg/kg.d,bid) and two antibiotics (Amoxicillin 30-50mg/kg.d bid, Clarithromycin 15-20mg/kg.d bid, Metronidazole15-20mg/kg.d bid) based on antibiotics susceptibility and cytochrome P450 isoenzyme 2C19 genotype. Eradication status will be reassessed in four weeks after treatment.
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
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of H. pylori infection.
- •Presence of upper gastrointestinal symptoms.
- •Referred for upper endoscopy at Beijing Children's Hospital
排除标准
- •Presence of endoscopy contraindications
- •The administration of any drug that could influence the study results including proton pump inhibitors, H2-receptor blockers, bismuth salts and antibiotics within the previous four weeks;
- •Gastrointestinal malignancy;
- •Previous gastric or esophageal surgery;
- •Severe concomitant diseases
- •History of allergy to any of the study drugs;
研究组 & 干预措施
Tailored Group
In tailored therapy, medications will be adjusted according to the antimicrobial susceptibility testing (including Clarithromycin sensitivity) and cytochrome P450 isoenzyme 2C19 genotype. 10 days regimen will be prescribed.
干预措施: Tailored Group (Drug)
Standard group
In standard triple therapy, children will be treated by Omeprazole(0.8-1.0mg/kg.d,bid), Amoxicillin (30-50mg/kg.d bid)and Clarithromycin (15-20mg/kg.d bid) for 10 days.
干预措施: Standard group (Drug)
结局指标
主要结局
Compare the eradication rates in each group
时间窗: One month after treatment
The efficacy of H. pylori eradication between the standard triple therapy and tailored therapy based on the results of antimicrobial resistance(including Clarithromycin sensitivity) by using H. pylori culture and cytochrome P450 isoenzyme 2C19 genotype. Eradication status will be reassessed in one month after treatment.
次要结局
未报告次要终点
研究者
Xiwei Xu
Chief of Gastroenterology Department
Beijing Children's Hospital