A Comparison of Four Different Treatment Regimens as the First-line Treatment of Helicobacter Pylori in Chinese Children and Investigation of Resistance and Impact factors-a Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Ying HUANG
- 入组人数
- 1,440
- 试验地点
- 1
- 主要终点
- 13C-UBT
研究概览
简要总结
With the resistance of Helicobacter pylori increasing, low and unsatisfactory eradication rate (64%) have been observed with standard triple therapy in European children. Which regimen is appropriate for Chinese children? There is no large scale, multi center studies in China about treatment, CYP2C19 gene polymorphism, resistance rate and resistance genotype. Investigators want to perform a research to compare four different treatment regimens（triple therapy, sequential therapy, bismuth quadruple therapy and concomitant therapy）as the first-line treatment of Helicobacter pylori in Chinese children and investigation of resistance, impact factors and changes of microbiota after the therapy. The results of the study will provide theoretical basis to make the new guideline of diagnosis and therapy of Helicobacter pylori in Chinese children. It advance instruct and norm the clinical practice for Chinese pediatrician to increase the cure rate of Helicobacter pylori and decrease the resistance.
详细描述
Eligible children were randomly divided into four groups: standard triple therapy, sequential therapy, bismuth quadruple therapy and concomitant therapy. The course of treatment is 14 days. The primary outcome measure was the Hp eradication rate at 4-6 weeks after completion of treatment which was confirmed by a negative of 13 UBT. Secondary outcome measures included side effects, impact factor and changes of microbiome after the therapy.
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children 6-18 years of age who were referred for upper endoscopy and confirmed to have Hp infection
排除标准
- •patients were excluded if they had taken proton pump inhibitors, H2-receptor antagonists or antibiotics in the 4 weeks prior to the study. Patients with known antibiotic allergy,hepatic impairment or kidney failure were also excluded. Patients who received Hp therapy before were also excluded.
研究组 & 干预措施
T-group
T-group(triple therapy)
干预措施: triple therapy (Drug)
S-group
S-group( sequential therapy)
干预措施: sequential therapy (Drug)
B-group
B-group( bismuth quadruple therapy )
干预措施: bismuth quadruple therapy (Drug)
C-group
C-group( concomitant therapy)
干预措施: concomitant therapy (Drug)
结局指标
主要结局
13C-UBT
时间窗: 13C-UBT was assessed at 4-6 weeks after completion of therapy
13C-UBT was used to determine whether Hp treatments was successful
次要结局
- side effects(assess at 2,4-6weeks after completion of the therapy)
- changes of Shannon diversity indices for gut microbiome(assess at 0,2,4-6weeks after completion of the therapy)
- changes of abundances for gut microbiome(assess at ,2,4-6weeks after completion of the therapy)
- CYP2C19 gene that impact the metabolism of PPI(detect the gene before the therapy)
- virulence gene-cagA(detect the gene before the therapy)
- patient compliance(assess compliance 2 weeks after the therapy)
- changes of OTU for gut microbiome(assess at 0,2,4-6weeks after completion of the therapy)
- virulence gene-vacA(detect the gene before the therapy)
研究者
Ying HUANG
The director of gastroenterology of Children's Hospital of Fudan
Children's Hospital of Fudan University