Does Helipyl Eradicate

Phase 4

Completed

• Conditions: Eradication
• Interventions: Other: lactobacillus reuteri DSMZ 17648

• Registration Number: NCT04618159
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Study Timeline

• Study First Submitted: 2018-10-08
• Study Start: 2019-02-10
• Primary Completion: 2019-06-01
• Study Completion: 2020-01-25
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-04
• Last Update Submitted: 2020-11-04
• Study First Posted: 2020-11-05
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

• helicobacter pylori infection with symptoms
• <5 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Helipyl	lactobacillus reuteri DSMZ 17648	helipyl wil be given to 10 children with asymptomatical helicobacter pylori infection

Primary Outcome Measures

Name	Time	Method
to evaluate the C13 breathtest	6months	evaluation of C13 breathtest before, at the end of treatment and one month after treatment

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Brussels, Brussel Hoofdstedelijk Gewest, Belgium