Does Helipyl Eradicate
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- to evaluate the C13 breathtest
研究概览
简要总结
Helipyl is on the market; actually it is a post-biotic because it is a killed Lactobacillus reuteri DSMZ 17648. The aim is to demonstrate (or not) that this product eradicates helicobacter, which it claims to do.
详细描述
This is a pilot project. There is quite limited literature on this product and Helicobacter pylori eradication. My personal opinion is that the literature and guidelines are contradictory. The European guideline is that Helicobacter pylori should not be corrected unless there are "serious" symptoms . On the other hand, Helicobacter is a carcinogen. Quite often, parents ask us, children's gastroenterologists, to screen their children for Helicobacter because they are symptomatic and are being eradicated, and know that Helicobacter is contagious. This creates a difficult situation: not answering the question is not an option according to the parents' opinion. Going into the question and eradicating "classic" is against all guidelines.
Hence this pilot project: 10 complaints-free carriers of Helicobacter pylori (> 5 years) will be treated with Helipyl for one month (product supplied by the company). Beforehand, at the end of the treatment and a month after stopping of the treatment, we do a C13 breath test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>5 and <18 years
- •male and female
- •asymptomatic helicobacter pylori
排除标准
- •helicobacter pylori infection with symptoms
- •<5 years
研究组 & 干预措施
Helipyl
helipyl wil be given to 10 children with asymptomatical helicobacter pylori infection
干预措施: lactobacillus reuteri DSMZ 17648 (Other)
结局指标
主要结局
to evaluate the C13 breathtest
时间窗: 6months
evaluation of C13 breathtest before, at the end of treatment and one month after treatment
次要结局
未报告次要终点
研究者
Yvan Vandenplas
head of departement
Universitair Ziekenhuis Brussel
