A Study on the Treatment Efficacy of Regimens With and Without Bismuth in Children With Helicobacter Pylori-Associated Peptic Ulcer Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Eradication rate of Helicobacter pylori infection between the two treatment regimens
研究概览
简要总结
The goal of this clinical trial is to learn if including bismuth in the treatment helps heal stomach and duodenal ulcers caused by Helicobacter pylori (H. pylori) in children.
The main questions it aims to answer are:
- Does a treatment plan with bismuth work better than a plan without bismuth to clear the infection?
- Is the bismuth plan more cost-effective while still safe and effective?
Researchers will compare two treatment groups to see which works better. Participants will:
- Take one of the two assigned treatment plans (with or without bismuth) for the standard treatment duration
- Visit the clinic for checkups and tests to confirm infection clearance and monitor side effects
- Keep a diary of symptoms, medication use, and any side effects
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with gastritis or peptic ulcer disease by upper gastrointestinal endoscopy or histopathology.
- •Meets diagnostic criteria for Helicobacter pylori infection.
- •Parent or legal guardian provides consent for the child to participate in the study.
排除标准
- •Allergic to any of the medications in the treatment regimen.
- •Use of antibiotics or bismuth within the past 4 weeks, or use of antacids, H2-receptor antagonists, or proton pump inhibitors within the past 2 weeks.
- •Failure to return for follow-up visits after treatment.
研究组 & 干预措施
Bismuth quadruple therapy
Patients in this arm will receive PPI, Amoxicillin, Metronidazole, and Bismuth for 14 days, with doses adjusted according to weight and age.
干预措施: Bismuth quadruple therapy (Drug)
Triple therapy with PPI + Amoxicillin + Metronidazole
Patients in this arm will receive PPI, Amoxicillin, Metronidazole for 14 days, with doses adjusted according to weight and age.
干预措施: Triple therapy with PPI + Amoxicillin + Metronidazole (Drug)
结局指标
主要结局
Eradication rate of Helicobacter pylori infection between the two treatment regimens
时间窗: Two weeks after discontinuation of acid suppression therapy following completion of the eradication regimen.
The efficacy of the two regimens will be evaluated by comparing H. pylori eradication rates. Clinical examination and a urea breath test or stool antigen test will be performed after completion of therapy to confirm eradication. Patients will receive a 14-day treatment regimen, followed by an additional 2-4 weeks of proton pump inhibitor (PPI) therapy to promote healing of gastric or duodenal lesions.
次要结局
未报告次要终点
研究者
Mai Thùy Trang
Doctor
Can Tho University of Medicine and Pharmacy