Effect of Gut Microbiota After High-dose Dual Therapy Combined With Probiotics for Helicobacter Pylori Eradication: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Gut Microbiota
研究概览
简要总结
The aim of this study was to evaluate the effect of gut microbiota after high-dose dual therapy combined with probiotics for Helicobacter pylori eradication
详细描述
The combination of vonoprazan (VPZ) and amoxicillin (VA therapy) has been shown to achieve notable eradication rates for Helicobacter pylori (H. pylori). Patients who receive this treatment are prone to adverse reactions, such as diarrhea, abdominal distention. We plan to combine probiotic therapy with the above treatment. However, it is not clear what changes in gut microbiota and metabolism may result from this 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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 65 years;
- •H.pylori infection diagnosed by 13C-urea breath test;
- •No history of H. pylori eradication.
排除标准
- •Allergy to amoxicillin;
- •Zollinger-Ellison syndrome, GC,upper gastrointestinal bleeding, or active peptic ulcer;
- •Coexistence of significant concomitant illnesses, including heart disease, renal failure, hepatic disease, previous abdominal surgery, lactation, or pregnancy;
- •Use of PPI and antibiotics within the previous one month;
- •Unwillingness to participate in this study.
研究组 & 干预措施
Group A
vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days, followed by 2 doses of bacillus subtilis enteric-coated capsules for 14 days.
干预措施: Vonoprazan (Drug)
Group A
vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days, followed by 2 doses of bacillus subtilis enteric-coated capsules for 14 days.
干预措施: Amoxicillin (Drug)
Group A
vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days, followed by 2 doses of bacillus subtilis enteric-coated capsules for 14 days.
干预措施: Bacillus subtilis enteric-coated capsules (Drug)
Group B
vonoprazan 20 mg bid + amoxicillin 0.75 g qid+ 2 doses of bacillus subtilis enteric-coated capsules for 14 days.
干预措施: Vonoprazan (Drug)
Group B
vonoprazan 20 mg bid + amoxicillin 0.75 g qid+ 2 doses of bacillus subtilis enteric-coated capsules for 14 days.
干预措施: Amoxicillin (Drug)
Group B
vonoprazan 20 mg bid + amoxicillin 0.75 g qid+ 2 doses of bacillus subtilis enteric-coated capsules for 14 days.
干预措施: Bacillus subtilis enteric-coated capsules (Drug)
Group C
2 doses of bacillus subtilis enteric-coated capsules for 14 days, followed by vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days.
干预措施: Vonoprazan (Drug)
Group C
2 doses of bacillus subtilis enteric-coated capsules for 14 days, followed by vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days.
干预措施: Amoxicillin (Drug)
Group C
2 doses of bacillus subtilis enteric-coated capsules for 14 days, followed by vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days.
干预措施: Bacillus subtilis enteric-coated capsules (Drug)
Group D
vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days.
干预措施: Vonoprazan (Drug)
Group D
vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days.
干预措施: Amoxicillin (Drug)
结局指标
主要结局
Gut Microbiota
时间窗: day 0, day 44 (or 58), day 104 (or 118)
Diversity and Compositional Analysis of Gut Microbiota is tested by Metagenomics.
次要结局
- Fecal Metabolites(day 0, day 44 (or 58), day 104 (or 118))
- Eradication rate(day 44 or day 58)
- Frequency of the adverse events(day 44 or day 58)
- Compliance rate of the drugs(day 44 or day 58)
- Small intestinal bacterial overgrowth(day 0, day 44 (or 58), day 104 (or 118))
研究者
Zhuyucheng
Deputy Chief Physician
Zhongshan Hospital (Xiamen), Fudan University