NCT04618159

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

February 10, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2020

Completed
10 months until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

4 months

First QC Date

October 8, 2018

Last Update Submit

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

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • helicobacter pylori infection with symptoms
  • \<5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Brussel

Brussels, Brussel Hoofdstedelijk Gewest, 1090, Belgium

Location

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: helipyl is given to patients with non symptomatic helicobacter pylori infection
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

Primary Completion

June 1, 2019

Study Completion

January 25, 2020

Last Updated

November 5, 2020

Record last verified: 2020-11

Locations

BE(1)