Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- platelet count
研究概览
简要总结
Previous studies suggest that chronic idiopathic thrombocytopenic purpura is associated with Helicobacter pylori infection. The objective is to study the effect of Helicobacter pylori eradication on platelet count.
详细描述
Children with chronic idiopathic thrombocytopenic purpura who have Helicobacter pylori infection are enrolled. Helicobacter pylori infection is diagnosed by urea breath test. Patients who have Helicobacter pylori infection will be randomized into 2 groups: control and treatment groups. The treatment group will receive 2 antibiotics and proton-pump inhibitors for 14 days for eradication of infection. Repeated urea breath test at week 6-8 after treatment. Blood tests for platelet count will be performed every month for 6 months in both groups. Platelet count at 6 months in both group will be compared.Blood for platelet antibody will be performed at 3 and 6 months. Control group will receive treatment for Helicobacter pylori at the end of the study.
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
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children who was diagnosed as chronic ITP, defined by platelets below 100,000/uL for more than 6 months without identified causes.
- •13C-urea breath test (UBT) was performed for diagnosis of Helicobacter pylori infection.
排除标准
- •Patients who had a previous treatment for H. pylori infection.
- •Patients require prednisolone more than 0.5 mg/kg/day
研究组 & 干预措施
I
Drug: lansoprazole, clarithromycin, amoxycillin
干预措施: lansoprazole, clarithromycin, amoxycillin (Drug)
结局指标
主要结局
platelet count
时间窗: 6 months
次要结局
- platelet antibody after treatment of Helicobacter pylori infection, compared with control group (no treatment of Helicobacter pylori)(6 months)
- platelet count(6 months)