Data Collection for the Creation of the French Pediatric Helicobacter Pylori Observatory
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,201
- 试验地点
- 1
- 主要终点
- Sex
研究概览
简要总结
Helicobacter pylori is a major human pathogen associated with significant morbidity. The treatment oriented by the antibiogram or PCR (Polymerase Chain Reaction) should be privileged in children. However, the optimal treatment for the eradication of pediatric H. pylori infection is still not established.
No French consensus conference on the management of H. pylori infection in children taking into account the epidemiological data available for this infection has been published. The description of diagnostic and therapeutic management procedures has not yet been specifically described according to the country of birth of children. The main objective is to collect data enabling the establishment of a French observatory of Helicobacter pylori in children in order to provide a national database.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child with confirmed H. pylori infection by direct diagnostic methods after periendoscopic gastric biopsies
- •Age < 18
- •No opposition of at least one of the 2 parents to the use of health data for research purposes
排除标准
- •Child with confirmed H. pylori infection by indirect diagnostic methods
结局指标
主要结局
Sex
时间窗: at inclusion
Clinical symptoms
时间窗: at inclusion, 3 and 6 months
Microbiological diagnosis
时间窗: at inclusion, 3 and 6 months
Age
时间窗: at inclusion
Rates of bacterial resistance profiles
时间窗: at inclusion, at 3 and 6 months
antibiotic therapy
时间窗: at inclusion, 3 and 6 months
Bacterial eradication rates
时间窗: 3 and 6 months
Side effects and tolerance of first and second line treatments
时间窗: 3 and 6 months
Endoscopic diagnosis
时间窗: at inclusion, 3 and 6 months
Diagnosis of H. pylori infection
时间窗: at inclusion
Child with confirmed H. pylori infection by direct diagnostic methods (Histology, Bacterial culture, PCR) on perendoscopic gastric biopsies
Country of birth
时间窗: at inclusion
次要结局
未报告次要终点