NCT04618159

CompletedPhase 4

Does Helipyl Eradicate

Universitair Ziekenhuis Brussel Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

2018-380

Study Type

interventional

Actual enrollment (reported)

10

Locations

1 country

Sites

1

Timeline

Study Start

February 10, 2019

Actual (reported)

Primary Completion

June 1, 2019

Actual (reported)

Study Completion

January 25, 2020

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 10 participants
Study completion date: January 25, 2020
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
October 8, 2018
Actual (reported)
Study Start
February 10, 2019
Actual (reported)
Primary Completion
June 1, 2019
Actual (reported)
Study Completion
January 25, 2020
Actual (reported)
First Posted
November 5, 2020
Actual (reported)

Last Updated: November 5, 2020
Status Verified: November 2020
Last Update Submitted: November 4, 2020

Conditions

Eradication

Outcome Measures

Primary Outcomes (1)

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

Study Arms (1)

Helipyl

OTHER

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

Other: lactobacillus reuteri DSMZ 17648

Interventions

lactobacillus reuteri DSMZ 17648Other

to evaluate if this product can eradicate helicobacter pylori

Helipyl

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age5 Years - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

\>5 and \<18 years
male and female

Sponsors & Collaborators

Universitair Ziekenhuis Brussel
Otherlead

Study Sites (1)

UZ Brussel

Brussels, Brussel Hoofdstedelijk Gewest, 1090, Belgium

Enrollment

10 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: NA
Masking: NONE
Purpose: DIAGNOSTIC
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: head of departement

Study Record Dates

First Submitted

October 8, 2018

First Posted

November 5, 2020

Study Start

February 10, 2019

Actual (reported)

asymptomatic helicobacter pylori

You may not qualify if:

helicobacter pylori infection with symptoms
\<5 years

Contact the study team to confirm eligibility.

Primary Completion

June 1, 2019

Actual (reported)

Study Completion

January 25, 2020

Actual (reported)

Last Updated

November 5, 2020

Record last verified: 2020-11

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04618159
Data provider: ClinicalTrials.gov
Source updated: 2020-11-05
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:40:20 UTC

Locations

BE(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

Primary Completion

Study Completion

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Helipyl

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations