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
| Type | Name | Description |
|---|---|---|
| OTHER | lactobacillus reuteri DSMZ 17648 | to 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.