Lacidophilin Tablets in Combination With Vonorazan and Amoxicillin Dual Therapy for Eradicating Helicobacter Pylori Infection: a Prospective, Multi-centers, Superiority, Double-blind, Randomized Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- Efficacy of Treatment
研究概览
简要总结
Our previous study included 119 Helicobacter pylori(H. pylori)-infected Chinese patients without previous eradication history who were randomized to low-or high-dose amoxicillin-vonoprazan regimens consisting of amoxicillin 1 gram either b.i.d. or t.i.d plus vonoprazan 20 mg b.i.d for 7 or 10 days. Neither 7-or 10-day VA dual therapy with either b.i.d. or t.i.d. amoxicillin achieved satisfied efficacy (i.e., <90%) when given as first-line treatment for H. pylori infection. Lacidophilin tablets have been reported to increase the eradication rate of H. pylori while reducing the incidence of adverse effects.This study evaluated the efficacy and safety of lacidophilin tablets in combination with amoxicillin-vonoprazan dual therapy for 10 days as first-line treatment for H. pylori in China.
详细描述
This study was designed as a prospective, multi-centers, double-blind, randomized superiority clinical study and was conducted in accordance with the Declaration of Helsinki and the guidelines of the Consolidated Standards of Reporting Trials.
Consecutive H. pylori-infected subjects ages from 18 to 70 without eradication history were recruited . H. pylori infection was confirmed by immunohistochemistry or urea breath test.
The H. pylori-infected subjects were randomly assigned to receive lacidophilin tablets or placebo in combination with amoxicillin-vonoprazan dual therapy for in a 1:1 allocation ratio, a randomization list was generated using Statistical Product Service Solutions (version 25.0).
The therapy consisted of 2400mg lacidophilin tablets or placebo three times daily, 1000 mg amoxicillin capsules three times daily and 20mg vonoprazan fumarate tablets twice daily for 10 days. The shape, taste, packaging, storage method and administration method of placebo are the same as lacidophilin tablets. Participants and investigators were blinded to the allocated treatment group.
At the start, the detailed demographics and characteristics of the subjects included in this study were recorded, including sex, age, nationality, height, weight, education status, dwelling area, history of smoking and alcohol, concomitant diseases and medication history. In addition, physical examinations and assessment of vital signs were performed. Gastric antrum and body biopsy of the included subjects were obtained during the endoscopy, which were followed by culture and susceptible test of antibiotics. Fecal sample was collected before eradication.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive H. pylori-infected subjects ages from 18 to 70 without eradication history
排除标准
- •allergy to amoxicillin,vonoprazan or lacidophilin tablets;
- •acute upper gastrointestinal bleeding, gastric cancer or other tumors, Zollinger-Ellison syndrome, history of gastric surgery;
- •gastroscopy report showing or past medical history of significant esophagogastric disease, including gastric cancer, peptic ulcer, esophagitis, esophageal erosion.
- •serious illness including neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, endocrinological or hematological disorders;
- •pregnancy or breast feeding;
- •proton pump inhibitors, antibiotics and probiotics use within one month;
- •not willing to participate in the study.
研究组 & 干预措施
Lacidophilin tablets group
2400mg lacidophilin tablets three times daily,1000mg amoxicillin capsules three times daily and 20mg vonoprazan Fumarate Tablets twice daily for 10 days
干预措施: Lacidophilin tablets in combination with vonorazan dual therapy (Drug)
Placebo group
2400mg placebo three times daily,1000mg amoxicillin capsules three times daily and 20mg vonoprazan Fumarate Tablets twice daily for 10 days
干预措施: Placebo in combination with vonorazan dual therapy (Drug)
结局指标
主要结局
Efficacy of Treatment
时间窗: 4-8 weeks after treatment
The confirmation of H. pylori status was evaluated by urea breath test
次要结局
- Incidence of Treatment-Emergent Adverse Events(1 day after eradication)
- Compliance of Participants(1 day after eradication)
- Resistance of Antibiotics(before the eradication)
- Alteration of Gut Microbiota(before eradication，1 day after eradication and confirmation（4-8 weeks after treatment）)
研究者
Lingyu Luo
Professor
The First Affiliated Hospital of Nanchang University