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Does Helipyl Eradicate

Does Helipyl Eradicate

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04618159
Acronym
Helipyl
Enrollment
10
Registered
2020-11-05
Start date
2019-02-10
Completion date
2020-01-25
Last updated
2020-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eradication

Brief 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.

Interventions

OTHERlactobacillus reuteri DSMZ 17648

to evaluate if this product can eradicate helicobacter pylori

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

helipyl is given to patients with non symptomatic helicobacter pylori infection

Eligibility

Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* \>5 and \<18 years * male and female * asymptomatic helicobacter pylori

Exclusion criteria

* helicobacter pylori infection with symptoms * \<5 years

Design outcomes

Primary

MeasureTime frameDescription
to evaluate the C13 breathtest6monthsevaluation of C13 breathtest before, at the end of treatment and one month after treatment

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026