To Compare the Efficacy of Nitrazoxinide Based Triple Therapy Versus Standard Triple Therapy for Eradication of Helicobacter Pylori Infection in Children at a Tertiary Care Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Treatment efficacy
研究概览
简要总结
This study aimed at comparing the efficacy of nitazoxanide-based triple therapy versus standard triple therapy for eradication of Helicobacter pylori infection in children at a tertiary care hospital.
详细描述
The findings could guide clinical practice and influence guidelines, improving the management of H. pylori infections in the pediatric population. Not much local data also exists comparing the effectiveness of adding nitazoxanide to the standard triple therapy in children with H. pylori infection. If nitazoxanide-based therapy proves superior, it could reduce the incidence of antibiotic resistance associated with standard triple 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
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any gender
- •Aged 2 to 12 years
- •With symptoms like abdominal pain, nausea, vomiting, or other related gastrointestinal symptoms
- •Diagnosed with H. pylori based on urea breath test
排除标准
- •Liver cirrhosis
- •Renal impairment
- •Previous gastric or duodenal surgery or malignancy
- •History of receiving H. pylori treatment
- •Past 6 weeks history of using antacids, H2 receptor antagonists, anticoagulants, or antibiotics
研究组 & 干预措施
NTZ-based group
Children in NTZ-based group were given triple regimen, i.e., nitazoxanide, PPI, and clarithromycin for 14 days.
干预措施: Nitazoxanide (Drug)
NTZ-based group
Children in NTZ-based group were given triple regimen, i.e., nitazoxanide, PPI, and clarithromycin for 14 days.
干预措施: PPI (Drug)
NTZ-based group
Children in NTZ-based group were given triple regimen, i.e., nitazoxanide, PPI, and clarithromycin for 14 days.
干预措施: Clarithromycin (Drug)
MTZ-based group
Children in MTZ-based triple regimen received metronidazole, PPI, and clarithromycin for 14 days.
干预措施: Metronidazole (Drug)
MTZ-based group
Children in MTZ-based triple regimen received metronidazole, PPI, and clarithromycin for 14 days.
干预措施: PPI (Drug)
MTZ-based group
Children in MTZ-based triple regimen received metronidazole, PPI, and clarithromycin for 14 days.
干预措施: Clarithromycin (Drug)
结局指标
主要结局
Treatment efficacy
时间窗: 6 weeks
The patients were considered clinically cured if they had a negative H. pylori stool Ag test and were free of symptoms at 6 weeks after starting treatment, or otherwise failure was labeled.
次要结局
未报告次要终点
研究者
Muhammad Aamir Latif
Research Consultant
RESnTEC, Institute of Research