A Study on the Efficacy and Safety of Egg Yolk Antibody in Adjuvant Treatment of Helicobacter Pylori Infection
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Eradication rate of Helicobacter pylori
研究概览
简要总结
Helicobacter pylori is an important pathogenic factor for gastrointestinal diseases such as gastritis, peptic ulcer, gastric mucosa-associated lymphoid tissue lymphoma and gastric cancer.However, with the increasing use of antibiotics, antibiotic resistance of Helicobacter pylori continues to rise. In this study, we used egg yolk antibody combined with bismuth quadruple therapy to treat patients with Helicobacter pylori infection, and observed the eradication rate of Helicobacter pylori, the relief of clinical symptoms and the incidence of adverse reactions.
详细描述
Background: Helicobacter pylori is an important pathogenic factor for gastrointestinal diseases such as gastritis, peptic ulcer, gastric mucosa-associated lymphoid tissue lymphoma and gastric cancer.However, with the increasing use of antibiotics, antibiotic resistance of Helicobacter pylori continues to rise. Therefore, it is of great significance to explore new methodsfor the treatment of Helicobacter pylori.
Methods: A total of 200 patients who failed to eradicate Helicobacter pylori were included and randomly divided into control group and study group. The research group was treated with egg yolk antibody combined with bismuth quadruple therapy, and the research group was treated with bismuth quadruple therapy for a total of 14 days. The eradication rate of Helicobacter pylori was calculated according to intention-to-treat and by-protocol analysis, and the symptom remission rate and adverse reactions were recorded during the treatment period.
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 (Care Provider, Outcomes Assessor)
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 to 70 years old, male or female;
- •Patients diagnosed with Hp infection;
- •Failure of Hp eradication therapy;
- •Although taking acid-suppressing drugs (PPI), the drug has been stopped for more than 2 weeks;
- •Those who have not used antibiotics and (or) bismuth in the past 4 weeks;
- •Understand and be willing to participate in this clinical trial and provide signed informed consent.
排除标准
- •Those with a history of allergy to drugs and egg yolk antibody products;
- •Those with severe heart, liver, lung and kidney insufficiency;
- •Those with a recent history of gastrointestinal bleeding, obstruction, perforation, tumor, and other serious organic diseases of the gastrointestinal tract;
- •Those with mental illness or mental disorder that cannot be expressed normally;
- •During the research period, those who are pregnant, breastfeeding, or have a childbearing plan recently;
- •There are other persons who are not suitable for clinical trials of drugs
- •No collaborators.
研究组 & 干预措施
study group
14-days therapy of Yolk antibody and ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline, bismuth
干预措施: Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth (Drug)
control group
14-days therapy of ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline, bismuth
干预措施: IIaprazole, Amoxicillin/Clarithromycin/Furazolidone, Doxycycline, Bismuth (Drug)
the case group
14-days therapy of Yolk antibody and ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline
干预措施: Yolk antibody and IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline (Drug)
the control group
14-days therapy of ilaprazole, clarithromycin/amoxicillin/furazolidone, doxycycline, bismuth
干预措施: IIaprazole, Amoxicillin/ Clarithromycin/Furazolidone, Doxycycline, Bismuth (Drug)
结局指标
主要结局
Eradication rate of Helicobacter pylori
时间窗: At four weeks after the completion of treatment (day 42±3)
Detected by 13C-urea breath test (13C-UBT) or 14C-urea breath test (14-UBT), Eradication rate=(Number of successful eradication / total number of eradication)\*100%
次要结局
- Relief of clinical symptoms (Symptom relief rate)(After drug treatment (day 14±3) and during follow-up (day 42±3))
- Adverse events(After drug treatment (day 14±3))