Eradication of Helicobacter Pylori With a Lactobacillus Reuteri Strain Combination (Strains DSM 17938 and ATCC PTA 6475) and a Proton Pump Inhibitor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Eradication
研究概览
简要总结
Meta-analyses involving >4000 subjects with probiotics added to antimicrobial Helicobacter pylori eradication therapy in populations with antibiotic resistance have reported a mean increase in eradication rate of 12.2%. It is unclear how to translate that result into clinical practice.
To evaluate whether administration of Lactobacillus reuteri plus a PPI without antibiotics would eradicate H. pylori infections.
This was a double-blind placebo-controlled randomized 2 site study of L. reuteri (2 x 108 CFU L. reuteri DSM 17938 plus 2 x 108 CFU L. reuteri ATCC PTA 6475) 7 times per day or matching placebo plus 20 mg pantoprazole b.i.d. for 4 weeks. Cure was defined by negative 13C-UBT, 4 weeks after therapy. Sample size was based on obtaining >50% cures to be clinically useful as monotherapy.
详细描述
Aim of study This double-blind study will assess if the combination of PPI and a strain combination (Gastrus) of L.reuteri can yield higher eradication rates if doses are increased and dose interval shortened. The aim is to achieve at least 50% eradication as assessed by UBT.
Study Product
Gastrus capsules:
2x108 CFU Lactobacillus reuteri DSM 17938 + 2x108 CFU Lactobacillus reuteri ATCC PTA 6475.
Placebo capsules:
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 (Participant, Investigator)
盲法说明
Placebo capsules were identical in shape, colour and taste to Gastrus capsules but without L. reuteri
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for upper endoscopy for any reason
- •Biopsy specimens indicative of Hp infection
- •13C-UBT indicative of Hp infection
- •> 18 years of age
- •Informed consent obtained
排除标准
- •Severe gastritis
- •Peptic ulcer
- •Pregnancy or lactation
- •Malignancy
- •Other clinically significant condition
- •Alcohol abuse
- •Drug abuse
- •Patients taking bismuth compounds, anti-secretory drugs, antibiotics or probiotics during 4 weeks preceding endoscopy
研究组 & 干预措施
L.Reuteri
Lactobacillus reuteri DSM 17938 + Lactobacillus reuteri ATCC PTA 6475 one tablet by mouth 7 times per day + Pantoprazole 20 mg twice a day for 28 days
干预措施: L.Reuteri (Other)
Placebo
Placebo one tablet by mouth 7 times per day + Pantoprazole 20 mg twice a day for 28 days
干预措施: L.Reuteri (Other)
结局指标
主要结局
Eradication
时间窗: Four weeks after post treatmetn assessed by Δ-13C-UBT
number of patients with H. pylori infection eradicated at 9 weeks assessed by Δ-13C-UBT \<5‰
次要结局
未报告次要终点
研究者
Ruggiero Francavilla
Professor
University of Bari