Helicobacter Pylori Eradication With Clostridum Butyricum Capsule and Bacillus Coagulans Tablets
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- helicobacter pylori eradication H.pylori eradication
研究概览
简要总结
This study aims at evaluating efficacy Clostridum Butyricum Capsule and Bacillus Coagulans Tablets in H. pylori eradication. It is hypothesized that Clostridum Butyricum Capsule , Bacillus Coagulans Tablets monotherapy or Clostridum Butyricum Capsule plus Bacillus Coagulans may have some positive effect on H. pylori eradication.
详细描述
The study will include three phases: screening, treatment and follow-up. Screening: during this phase subjects eligibility will be evaluated after informed consent signature. Endoscopy and 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 8weeks.
Follow-up: includes one visits. 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 18~70,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 to study drugs.
- •Substantial organ impairment, 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).
- •Pregnant or lactating women.
- •Patients were diagnosed with gastroduodenal ulcer and MALT lymphoma.
- •Underwent upper gastrointestinal Surgery.
- •Patients with Barrett esophageal or highly atypical hyperplasia, have symptom of dysphagia.
- •Evidence of bleeding or iron efficiency 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).
- •Enrolled in other clinical trials in the past 3 months.
- •Patients who has psychological problem or poor compliance.
- •Refuse to sign informed consent.
研究组 & 干预措施
Clostridum Butyricum Capsule
Clostridum Butyricum Capsule 3*420mg, twice daily for 8 weeks
干预措施: Clostridum Butyricum Capsule (Drug)
Bacillus Coagulans Tablets
Bacillus Coagulans Tablets 3*350mg, three times daily for 8 weeks
干预措施: Bacillus Coagulans Tablets (Drug)
Clostridum Butyricum Capsule plus Bacillus Coagulans Tablets
Clostridum Butyricum Capsule 3*420mg, twice daily for 8 weeks and Bacillus Coagulans Tablets 3*350mg, three times daily for 8 weeks
干预措施: Clostridum Butyricum Capsule plus Bacillus Coagulans Tablets (Drug)
结局指标
主要结局
helicobacter pylori eradication H.pylori eradication
时间窗: 8 weeks
Rate of H.pylori eradication Assessed by urea breath test，rapid urease test or helicobacter pylori stool antigen test after the end of treatment.
次要结局
未报告次要终点
研究者
Yongquan Shi
Principal Investigator, Clinical Professor
Xijing Hospital of Digestive Diseases