Clinical Study on Bifidobacterium Quadruple Live Bacteria Tablets (Si Lian Kang) Reducing the Incidence Rate of Adverse Reactions in Helicobacter Pylori Quadruple Eradication Therapy and on the Effects of Gastrointestinal Flora
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 238
- 试验地点
- 2
- 主要终点
- the total incidence rate of digestive tract related adverse reactions
研究概览
简要总结
The purpose of this clinical trial is to evaluate the clinical efficacy of Bifidobacterium quadruple live bacteria tablets (Si Lian Kang) on reducing the incidence rate of adverse reactions of Helicobacter pylori quadruple eradication therapy and its influence on gastrointestinal flora.
详细描述
Bismuth agent quadruple therapy (including bismuth agent and proton pump inhibitor combined with two antibiotics) is the first-line strategy to eradicate Helicobacter pylori in China. However, it may cause a series of adverse reactions, such as nausea, diarrhea, abdominal pain, constipation, and abnormal taste, etc., which leads to a decrease in patient compliance, thereby affecting the treatment effect. Many studies have found that adding probiotics to traditional Helicobacter pylori eradication therapies increase eradication rates and reduce the side effects of the treatment. Bifidobacterium tetrad live bacteria tablet is a compound microecological preparation composed of bifidobacterium infantis, lactobacillus acidophilus, enterococcus faecalis and bacillus cereus. This study aims to observe the clinical efficacy of Bifidobacterium quadruple live bacteria tablets (Si Lian Kang) on reducing the incidence rate of adverse reactions in Helicobacter pylori quadruple eradication therapy and on the effects of gastrointestinal flora.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Voluntarily signing the informed consent form;
- •Aged 18-65 years old(including 65), male or female;
- •Patients aged 35-65 years old(including 35) with positive Helicobacter pylori should undergo gastroscopy, and the gastroscopy report shows normal or chronic gastritis;
- •Patients aged 18-35 years (including 18) with positive Helicobacter pylori are not required to perform gastroscopy examination if there is no obvious clinical symptoms, or applying report of gastroscopy within 6 months showing normal or chronic gastritis.
排除标准
- •Gastroscopy report or previous medical history showed significant esophagus-gastric diseases, including gastric cancer, peptic ulcer, oesophagitis and esophageal erosion;
- •Patients with chronic diarrhea and chronic functional constipation;
- •Other systemic diseases, including cardiovascular diseases, lung diseases, liver diseases (transaminase index is more than 2 times higher than the normal value), kidney diseases (creatinine index is higher than the normal value) and other important organs with severe lesions, severe metabolic diseases (diabetes, thyroid diseases), malignant tumors, and severe immune system diseases;
- •Abnormal stool routine results: fecal occult blood (+) or white blood cells (+);
- •Patients with severe psychological or mental diseases;
- •Those with a history of drug abuse or alcohol abuse;
- •Those who are allergic to the drugs in this study;
- •Those who have received Helicobacter pylori eradication therapy;
- •Drugs which affect the intestinal flora(including antibacterial drugs, microecological preparations, intestinal mucosal protectors, Chinese patent medicines, etc.) have been used in the past 1 month or need to be used continuously for more than 1 week in the experiment.
- •Pregnant or lactating women;
- •Participating or after completing other clinical trials Less than 3 months;
- •Others who researchers consider unsuitable for inclusion.
研究组 & 干预措施
probiotics plus standard therapy
干预措施: Bifidobacterium tetrad live bacteria tablet plus Helicobacter pylori quadruple eradication therapy (Drug)
placebo plus standard therapy
干预措施: Bifidobacterium tetrad live bacteria tablet placebo plus Helicobacter pylori quadruple eradication therapy (Drug)
结局指标
主要结局
the total incidence rate of digestive tract related adverse reactions
时间窗: baseline, 28 days, 182days
The patient diary cards (including Bristol stool classification, diarrhea, constipation, abdominal pain, abdominal distension, belching, nausea, vomiting, loss of appetite and changes in taste) are filled in daily from the -14th day to 28th day. The above contents are recorded weekly from the 29th to182th day. to calculate the total incidence rate of digestive tract related adverse reactions mentioned above
次要结局
- stool frequency(baseline, 28 days, 182days)
- the incidence rate of various digestive tract related symptoms(baseline, 28 days, 182days)
- duration of various digestive tract related symptoms(baseline, 28 days, 182days)
- changes in intestinal flora(baseline, 14 days, 28 days, 70 days, 182days)
- adverse events(28 days,182 days)
- changes in gastric flora(baseline, 70 days)
- Helicobacter pylori eradication rate(70 days)