Optimization of Minocycline-containing Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment: a Multicentre, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 476
- 试验地点
- 4
- 主要终点
- Helicobacter pylori eradication rate
研究概览
简要总结
The efficacy of bismuth-containing quadruple therapy with minocycline and metronidazole was not inferior to classical bismuth quadruple therapy for refractory H. pylori infection, though also accompanied with high occurrence of adverse events (55.4%). Optimization of minocycline-based regimen to achieve high eradication rate with fewer adverse events is imperative. This study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy with different dosage of minocycline and metronidazole compared to classical bismuth quadruple 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability and willingness to participate in the study and to sign and give informed consent
- •Confirmed H. pylori infection and with previous treatment experience
排除标准
- •subjects naive to H. pylori treatment,
- •under 18 or over 80 years old
- •history of gastrectomy
- •pregnant or lactating women
- •Previous history of tuberculosis
- •Allergy to any of the study drugs
- •severe systemic diseases or malignancy
- •administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks
研究组 & 干预措施
Minocycline group A
Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Minocycline 50mg tid, Metronidazole 400mg tid
干预措施: Vonoprazan (Drug)
Minocycline group A
Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Minocycline 50mg tid, Metronidazole 400mg tid
干预措施: Bismuth Potassium Citrate (Drug)
Minocycline group A
Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Minocycline 50mg tid, Metronidazole 400mg tid
干预措施: Minocycline,Metronidazole (Drug)
Minocycline group B
Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Minocycline 50mg bid, Metronidazole 400mg qid
干预措施: Vonoprazan (Drug)
Minocycline group B
Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Minocycline 50mg bid, Metronidazole 400mg qid
干预措施: Bismuth Potassium Citrate (Drug)
Minocycline group B
Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Minocycline 50mg bid, Metronidazole 400mg qid
干预措施: Minocycline,Metronidazole (Drug)
Minocycline group C
Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Minocycline 50mg bid, Metronidazole 400mg tid
干预措施: Vonoprazan (Drug)
Minocycline group C
Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Minocycline 50mg bid, Metronidazole 400mg tid
干预措施: Bismuth Potassium Citrate (Drug)
Minocycline group C
Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Minocycline 50mg bid, Metronidazole 400mg tid
干预措施: Minocycline,Metronidazole (Drug)
Tetracycline group
Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid
干预措施: Vonoprazan (Drug)
Tetracycline group
Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid
干预措施: Bismuth Potassium Citrate (Drug)
Tetracycline group
Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid
干预措施: Tetracycline,Metronidazole (Drug)
结局指标
主要结局
Helicobacter pylori eradication rate
时间窗: Six weeks after completion of therapy
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value).
次要结局
- Rate of adverse effects(Within 7 days after completion of therapy)
- Compliance rate(Within 7 days after completion of therapy)
研究者
Hong Lu, MD
Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine
RenJi Hospital