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Does Helipyl Eradicate

NCT ID: NCT04618159

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-10

Study Completion Date

2020-01-25

Brief Summary

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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

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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

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Eradication

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

helipyl is given to patients with non symptomatic helicobacter pylori infection
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Helipyl

helipyl wil be given to 10 children with asymptomatical helicobacter pylori infection

Group Type OTHER

lactobacillus reuteri DSMZ 17648

Intervention Type OTHER

to evaluate if this product can eradicate helicobacter pylori

Interventions

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lactobacillus reuteri DSMZ 17648

to evaluate if this product can eradicate helicobacter pylori

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* helicobacter pylori infection with symptoms
* \<5 years
Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Yvan Vandenplas

head of departement

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UZ Brussel

Brussels, Brussel Hoofdstedelijk Gewest, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2018-380

Identifier Type: -

Identifier Source: org_study_id