Effects of Helicobacter Pylori Eradication Therapy in Children With Chronic Immune Thrombocytopenic Purpura
试验速览
- 阶段
- 4 期
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- effects of Helicobacter pylori infection eradication on platelet counts of chronic immune thrombocytopenic patients
研究概览
简要总结
Thrombocytopenia refers to a reduction in platelet count to (<150 × 109/L). Immune thrombocytopenic purpura is an acquired autoimmune disorder defined by isolated thrombocytopenia and the exclusion of other causes of thrombocytopenia
详细描述
Helicobacter pylori was recently demonstrated as an etiological factor in immune thrombocytopenic purpura in some prospective studies, with reports of platelet numbers increasing in these patients after Helicobacter pylori eradication treatment.However, other studies have shown a negative result after eradication treatment of Helicobacter pylori infection in patients with chronic immune thrombocytopenic purpura, leading to controversy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic immune thrombocytopenic purpura patients who still have thrombocytopenia > 12 months
- •age <18 years .
- •diagnosis of immune thrombocytopenic purpura according to American Society of Hematology criteria based on an initial platelet count <100×103/μL .
- •Patients diagnosed as steroid and immunoglobulin resistant chronic immune thrombocytopenic purpura .
- •exclusion criteria:
- •Patients with acute immune thrombocytopenic purpura . .
- •age >18 years.
- •thrombocytopenia was related to autoimmune disorders, drugs, a family history consistent with inherited thrombocytopenia, human immunodeficiency virus infection, hepatitis.
- •previous history of Helicobacter pylori eradication; and history of medication with proton pump inhibitors, H2- receptor antagonists, or antibiotics in the previous 4 weeks.
排除标准
- 未提供
研究组 & 干预措施
Helicobacter pylori positive patients with intervention
chronic immune thrombocytopenic purpura patients who will be diagnosed positive for Helicobacter pylori infection using detection of Helicobacter pylori antigen in stool of these patients will receive treatment of Helicobacter pylori: Amoxicillin for 14 days, Clarithromycin for 14 days and Proton pump inhibitor for one month).
干预措施: Amoxicillin 50 mg/kg/day in 2 divided doses for 14 days. (Drug)
Helicobacter pylori positive patients with intervention
chronic immune thrombocytopenic purpura patients who will be diagnosed positive for Helicobacter pylori infection using detection of Helicobacter pylori antigen in stool of these patients will receive treatment of Helicobacter pylori: Amoxicillin for 14 days, Clarithromycin for 14 days and Proton pump inhibitor for one month).
干预措施: Clarithromycin 15 mg/kg/day in 2 divided doses for 14 days. (Drug)
Helicobacter pylori positive patients with intervention
chronic immune thrombocytopenic purpura patients who will be diagnosed positive for Helicobacter pylori infection using detection of Helicobacter pylori antigen in stool of these patients will receive treatment of Helicobacter pylori: Amoxicillin for 14 days, Clarithromycin for 14 days and Proton pump inhibitor for one month).
干预措施: Proton pump inhibitor 1 mg/kg/day in 2 divided doses 1 month (Drug)
结局指标
主要结局
effects of Helicobacter pylori infection eradication on platelet counts of chronic immune thrombocytopenic patients
时间窗: 6 months
platelet counts will be measured at the start of the study ,before the starting of the interventions, and after 6 months. platelet response will be classified as: 1-complete response: platelet count\> 150 × 109/L , 2-partial response: platelet count : 50-150 × 109/L , no response: platelet count \< 50 × 109/L.
次要结局
未报告次要终点
研究者
Mary Makram Kamel
principal investigator
Assiut University