Study on the Effect of Fucoidan Combined With the Eradication Program Containing Vonoprazan on H.Pylori Eradication Rate and Gastrointestinal Flora.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- compare eradication rates of the two groups by 13C-UBT
研究概览
简要总结
The purpose of this study is to investigate whether the eradication rate of H.pylori will be improved when adding fucoidan to the duplex scheme combination of amoxicillin and vonoprazan, and to explore the effect of fucoidan on gastrointestinal flora of patients.
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirement will be included in this simultaneous blind test. A total of 60 patients with HP infection were enrolled in this study. All patients were randomly divided into two groups according to the ratio of 1:1. Group A was given vonoprazan 20mg bid, amoxicillin 1000mg TID, fucoidan 1000mg bid for 14 consecutive days; Group B was given vonoprazan 20mg bid and amoxicillin 1000mg TID for 14 days. On the 10th and 14th days of treatment, the researchers will follow up the patients' adverse reactions and medication compliance. The feces of the subjects were collected one day before the treatment, and on the 14th and 44th days after the treatment; After 4 weeks of drug withdrawal, all subjects will be reexamined with 13C-UBT.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years old;
- •Patients diagnosed as HP positive;
- •Patients who have not received HP eradication treatment in the past, or who have failed in the early eradication but have not received eradication treatment within half a year;
- •Voluntarily participate in this trial and sign the informed consent form.
排除标准
- •Allergic to the study drug (penicillin allergy, etc.);
- •Patients with chronic gastritis and peptic ulcer;
- •Patients who have received HP eradication treatment within half a year;
- •Antibiotics and bismuth agents were used 4 weeks before the start of the study treatment, and histamine H2 receptor antagonists or PPIs were used 2 weeks before the start of the study treatment;
- •Use adrenocortical hormones, non steroidal anti-inflammatory drugs or anticoagulants;
- •History of esophageal or gastric surgery;
- •Pregnant and lactating women;
- •Suffering from serious accompanying diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease;
结局指标
主要结局
compare eradication rates of the two groups by 13C-UBT
时间窗: 6 weeks
Compare the eradication rate of Helicobacter pylori between the fucoidan containing group and the fucoidan free group
Analysis of intestinal flora difference before and after eradication using 16s rRNA sequencing
时间窗: 6 weeks
Analyze and compare the early and long-term changes of intestinal flora before and after eradication. Explore the effect of fucoidan on intestinal flora of patients receiving eradication treatment.
次要结局
未报告次要终点
研究者
Zhenyu Zhang
Director of Gastroenterology
Nanjing First Hospital, Nanjing Medical University