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临床试验/NCT04618159
NCT04618159已完成4 期

Does Helipyl Eradicate

Universitair Ziekenhuis Brussel1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年2月10日最近更新:
适应症
干预措施

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

Other

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yvan Vandenplas

head of departement

Universitair Ziekenhuis Brussel

研究点 (1)

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