The Role of Probiotics in the Eradication of Helicobacter Pylori
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 660
- 试验地点
- 5
- 主要终点
- Prevention of antibiotic side effects
研究概览
简要总结
All patients will receive quadruple eradication therapy for 10 days with Omerazole 20mg x2, Amoxicilin 1g x2, Clarithromycin 500mg x2 and Metronidazole 500mg x2. The patients will be randomised into two groups. The first group will receive one capsule of probiotics x2 two hours before or after meal for 15 days and the second group placebo (capsule with same composition and colour with probiotic) x2, two hours before or after meal for 15 days as well.
The probiotic (Lactolevure, Uni-Pharma, Athens) contains four probiotic strains known for their effectivness and safety, Saccharomyces Boulandrii (1.5 BU/capsule), Bifidobacterium Lactis BB-12 (1.75 BU/capsule), Lactobacillus Acidodophilus LA-5 (1.75 BU/capsule) and Lactobacillus Plantarum (0.5 BU/capsule).
详细描述
Patients with H.Pylori infection establised after a uper GI endoscopy and gastric biopsy will receive quadruple eradication therapy for 10 days with Omerazole 20mg x2, Amoxicilin 1g x2, Clarithromycin 500mg x2 and Metronidazole 500mg x2. The patients will be randomised into two groups. The first group will receive one capsule of probiotics x2 two hours before or after meal for 15 days and the second group placebo (capsule with same composition and colour with probiotic) x2, two hours before or after meal for 15 days as well.
The probiotic contains four probiotic strains known for their effectivness and safety, Saccharomyces Boulandrii (1.5 BU/capsule), Bifidobacterium Lactis BB-12 (1.75 BU/capsule), Lactobacillus Acidodophilus LA-5 (1.75 BU/capsule) and Lactobacillus Plantarum (0.5 BU/capsule).
Patients will report in a specific questionnare the presence or absence of symptoms suggestive of side effects associated with the Abx administered (i.e flatulance, abdominal pain, diarrhoea, regurgitation, vomiting).
All patints will be subjected to urea breath test one month after the completion of treatment in order to verify HP eradication.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Established Helicobacter Pylori Infection
排除标准
- •Pregnancy
- •Previous eradication therapy for HP.
- •Course of antibiotics and/or probiotics one month prior to stydy entry
- •Course of PPI's, H2- antagonst and antacids two weeks prior to study entry
- •Known allergy to antibiotics that will be used in study
- •Coronary disease, heart failure,malignancy,thyroid disease, pulmonary disease or other serious disease as per medical judgment
研究组 & 干预措施
Lactolevure
Patients will receive quadruple eradication therapy for Helicobacter Pylori infection with Amoxicillin, Clarithromycin, Metronidazole, Omeprazole and Probiotics
干预措施: Caps Lactolevure (Drug)
Placebo
Patients will receive quadruple eradication therapy for Helicobacter Pylori infection with Amoxicillin, Clarithromycin, Metronidazole, Omeprazole and Placebo
干预措施: Caps Placebo (Drug)
结局指标
主要结局
Prevention of antibiotic side effects
时间窗: Through study completion, an average of 1 year
Primary prevention of Abx side effects as assessed by a questionnaire including all possible side effects (i.e. vomiting, diarrhea, flatulence etc) on a ten point Likert scale.
次要结局
未报告次要终点
研究者
Nikos Viazis
Consultant Gastroenterology
Evangelismos Hospital