The Efficacy of Quadruple Therapy Containing Sodium Bicarbonate as the Primary Treatment for Helicobacter Pylori Infection
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 855
- 主要终点
- Helicobacter pylori eradication rate
研究概览
简要总结
The goal of this clinical trial is to learn the efficacy of sodium bicarbonate-containing quadruple therapy as the primary treatment for Helicobacter pylori infection. The main questions it aims to answer are:
Can sodium bicarbonate replace bismuth or clarithromycin in the classic quadruple therapy for the primary treatment of Helicobacter pylori infection? What is the safety and cost-effectiveness of sodium bicarbonate replacing bismuth or clarithromycin in the classic quadruple therapy for the primary treatment of Helicobacter pylori infection?
Researchers will compare sodium bicarbonate replacing bismuth or clarithromycin in the classic quadruple therapy to see the efficacy of sodium bicarbonate as an alternative to bismuth or clarithromycin in the classic quadruple therapy for the primary treatment of Helicobacter pylori infection.
Participants will： Take Helicobacter pylori treatment drugs for 14 days Recheck 13C-UBT or 14C-UBT breath test 6-8 weeks after eradication treatment Incidence of adverse reactions (AEs) and patient compliance
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
- •Aged 18-65 years, no history of eradication therapy;
- •Diagnosed with Helicobacter pylori infection by one or more of the following methods: gastric mucosal histochemical staining, tissue culture, 14C-UBT, 13C-UBT and/or fecal antigen;
- •Patients with warning symptoms, family history of gastric cancer or over 40 years old should undergo endoscopic examination before eradication therapy;
- •Voluntarily participate in clinical trials and sign informed consent.
排除标准
- •Use of antibiotics or bismuth within 4 weeks before enrollment, or use of acid suppressants (including H2RA, PPI or P-CAB) within 2 weeks;
- •Active peptic ulcer with complications such as bleeding, perforation or obstruction;
- •History of esophagectomy or gastrectomy;
- •Allergy to any study drug;
- •Pregnancy or lactation;
- •History of alcoholism or drug abuse;
- •Mental illness;
- •Incapacity for civil conduct.
研究组 & 干预措施
Classic quadruple therapy
Esomeprazole 20 mg BID Bismuth pectin 200 mg BID Amoxicillin 1 g BID Clarithromycin 500 mg BID for 14 days
干预措施: Classic quadruple therapy (Drug)
Quadruple therapy with sodium bicarbonate instead of bismuth
Esomeprazole 20 mg BID Sodium bicarbonate 500 mg TID Amoxicillin 1 g BID Clarithromycin 500 mg BID for 14 days
干预措施: Quadruple therapy with sodium bicarbonate instead of bismuth (Drug)
Quadruple therapy with sodium bicarbonate instead of clarithromycin
Esomeprazole 20 mg BID Bismuth pectin 200 mg BID Amoxicillin 1 g BID Sodium bicarbonate 500 mg TID for 14 days
干预措施: Quadruple therapy with sodium bicarbonate instead of clarithromycin (Drug)
结局指标
主要结局
Helicobacter pylori eradication rate
时间窗: 6-8 weeks after eradication treatment
Repeat 13C-UBT or 14C-UBT breath test, negative results (\<4.0‰, delta over baseline, 13C-UBT DOB; \<100, DPM, 14C-UBT) indicate successful eradication. Patients are not allowed to take PPIs or P-CAB drugs 2 weeks before the breath test, and are not allowed to take antibiotics 4 weeks before the breath test.
次要结局
- Incidence of adverse reactions (AEs)(One month after finishing with therapy)
- Compliance of patients(One month after finishing with therapy)