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The Effect of Probiotic Combination on Helicobacter Pylori Infection in Children

NCT02645201 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-08-22

No results posted yet for this study

Summary

The combination of two Lactubacillus reuteri strains, ATC 55730 and ATCC PTA 6457 are marketed as GASTRUS® and has been proposed as better option in increasing Helicobacter pylori eradication rate compared to the single strain ATC 55730, due to additional anti-inflammatory properties of the second strain.

Objectives of the study are to determine whether adding probiotic combination (GASTRUS®) to an anti- Helicobacter pylori regimen decreases adverse events and increases the eradication rate of Helicobacter pylori in the pediatric population infected with Helicobacter pylori bacteria.

Conditions

  • Helicobacter Infections

Interventions

DIETARY_SUPPLEMENT

Gastrus

to compare Gastrus 4x108 tbl twice a day to placebo tbl

OTHER

Placebo

to compare Gastrus 4x108 tbl twice a day to placebo tbl

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    lead OTHER

Principal Investigators

  • Matjaz Homan, MD PhD · University Medical Centre Ljubljana

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-08-18
Completion
2017-08-18

Countries

  • Belgium
  • Croatia
  • Germany
  • Israel
  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02645201 on ClinicalTrials.gov