Helicobacter Pylori Eradication Clostridium Butyricum Capsule and Bacillus Coagulans Tablets With Hydrochloride,Esomeprazole,Amoxicillin and Bismuth-containing Quadruple Therapy: a Randomized,Single-center，Open-label,Phase Ⅳ Trail
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- helicobacter pylori eradication
研究概览
简要总结
This study aims at evaluating efficacy and safety of probiotics combined with triple therapy (Clostridium butyricum capsule and Bacillus coagulans tablets, esomeprazole, clarithromycin and amoxicillin) versus bismuth-containing quadruple therapy (bismuth,esomeprazole,clarithromycin and amoxicillin) in H. pylori eradication. It is hypothesized that probiotics combined with triple therapy is non-inferior to bismuth-containing quadruple therapy. Patients with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 2 and 6 follow-up visits, a urea breath test(UBT) will be performed to confirm eradication.
详细描述
The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 28 days and subjects eligibility will be evaluated after informed consent signature. Urea Breath test will be performed in addition to the baseline routine evaluations.
Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 12 and 14.
Follow-up: includes two visits. approximately 14 days of treatment and 28 days after the end of treatment. Eradication of H. Pylori will be confirmed through urea breath test(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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18~75,both gender.
- •Patients with upper gastrointestinal symptoms and with documented H.pylori infection.
- •Patients are willing to receive eradication treatment.
- •Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter.
排除标准
- •Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.
- •contraindications or allergies to research drugs.
- •Substantial organ impairment(eg liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine disease.
- •Constant use of anti-ulcer drugs ( including taking proton-pump. inhibitors(PPI) within 2 weeks before the [13C] urea breath test), antibiotics or bismuth complexes (more than 3 times /1 month before screening).
- •Definite diagnosis of gastroduodenal ulcer and MALT's lymphoma.
- •Pregnant or lactating women.
- •Underwent upper gastrointestinal Surgery.
- •highly atypical hyperplasia, have symptom of dysphagia.
- •Evidence of bleeding or iron eficiency anemia.
- •A history of malignancy.
- •Drug or alcohol abuse history in the past 1 year.
- •Systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
- •a person with a mental disorder
- •Enrolled in other clinical trials in the past 3 months.
- •Refusal to sign informed consent.
研究组 & 干预措施
Clostridium butyricum group
given for 14 days at a dose of Clostridium butyricum capsule 420mg 3 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.
干预措施: Clostridium butyricum capsule (Drug)
Clostridium butyricum group
given for 14 days at a dose of Clostridium butyricum capsule 420mg 3 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.
干预措施: esomeprazole (Drug)
Clostridium butyricum group
given for 14 days at a dose of Clostridium butyricum capsule 420mg 3 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.
干预措施: amoxicillin (Drug)
Clostridium butyricum group
given for 14 days at a dose of Clostridium butyricum capsule 420mg 3 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.
干预措施: clarithromycin (Drug)
Bacillus clotting group
given for 14 days at a dose of Bacillus coagulans tablets 350mg 3 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.
干预措施: esomeprazole (Drug)
Bacillus clotting group
given for 14 days at a dose of Bacillus coagulans tablets 350mg 3 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.
干预措施: amoxicillin (Drug)
Bacillus clotting group
given for 14 days at a dose of Bacillus coagulans tablets 350mg 3 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.
干预措施: clarithromycin (Drug)
Bacillus clotting group
given for 14 days at a dose of Bacillus coagulans tablets 350mg 3 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.
干预措施: Bacillus clotting (Drug)
bismuth quadruple therapy
given for 14 days at a dose of colloidal bismuth tartrate capsule 55 mg 4 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.
干预措施: esomeprazole (Drug)
bismuth quadruple therapy
given for 14 days at a dose of colloidal bismuth tartrate capsule 55 mg 4 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.
干预措施: amoxicillin (Drug)
bismuth quadruple therapy
given for 14 days at a dose of colloidal bismuth tartrate capsule 55 mg 4 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.
干预措施: clarithromycin (Drug)
bismuth quadruple therapy
given for 14 days at a dose of colloidal bismuth tartrate capsule 55 mg 4 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.
干预措施: Bismuth (Drug)
结局指标
主要结局
helicobacter pylori eradication
时间窗: 28 days after treatment
The primary end point of this study is H.pylori eradication,established by negative \[13C\] urea breath test 28 days after the end of eradication.
次要结局
- symptoms effective rates(14 days of treatment, and 28 days after treatment)
- adverse events(14 days of treatment, and 28 days after treatment)
研究者
Yongquan Shi
Professor/Chief Physician
Xijing Hospital of Digestive Diseases