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OpenTrials
Completed

NCT Number: NCT04618159

Does Helipyl Eradicate

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.

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Key information

Conditions

Eradication

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UZ Brussel

Brussels, Brussel Hoofdstedelijk Gewest, 1090, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >5 and <18 years
  • male and female
  • asymptomatic helicobacter pylori

Exclusion criteria

  • helicobacter pylori infection with symptoms
  • <5 years

Treatment and study plan

lactobacillus reuteri DSMZ 17648

Other

to evaluate if this product can eradicate helicobacter pylori

Primary outcomes

  1. to evaluate the C13 breathtest

    Time frame: 6months

    evaluation of C13 breathtest before, at the end of treatment and one month after treatment

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Acronym: Helipyl

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Nov 5, 2020
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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