Clinical Trials Directory

Trials / Completed

CompletedNCT04618159

Does Helipyl Eradicate

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
10 (actual)
Sponsor
Universitair Ziekenhuis Brussel · Academic / Other
Sex
All
Age
5 Years – 17 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERlactobacillus reuteri DSMZ 17648to evaluate if this product can eradicate helicobacter pylori

Timeline

Start date
2019-02-10
Primary completion
2019-06-01
Completion
2020-01-25
First posted
2020-11-05
Last updated
2020-11-05

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT04618159. Inclusion in this directory is not an endorsement.