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The Effect of a Multispecies Probiotic on Reducing the Incidence of Antibiotic-associated Diarrhoea in Children.

NCT03334604 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2021-10-07

No results posted yet for this study

Summary

In this trial, the investigators aim to assess the effectiveness of a multispecies probiotic consisting of 2 strains of Bifidobacterium (B. bifidum W23, B. lactis W51) and 6 strains of Lactobacillus (L. acidophilus W37, L. acidophilus W55, L. paracasei W20, L. plantarum W62, L. rhamnosus W71, and L. salivarius W24) in reducing the risk of antibiotic-associated diarrhoea in a group of children undergoing antibiotic therapy for common infections.

Conditions

  • Antibiotic-associated Diarrhea

Interventions

DIETARY_SUPPLEMENT

Multispecies probiotic

Multispecies probiotic consisting of Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Lactobacillus acidophilus W37, Lactobacillus acidophilus W55, Lactobacillus paracasei W20, Lactobacillus plantarum W62, Lactobacillus rhamnosus W71 and Lactobacillus salivarius W24 at a dose of 5x10\^9 Colony Forming Units (CFU), twice daily, orally.

OTHER

Placebo

Placebo identical in taste, smell and color to the multispecies probiotic.

Sponsors & Collaborators

  • Winclove Probiotics B.V.

    collaborator INDUSTRY

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Jan Łukasik, MD · Department of Paediatrics, The Medical University of Warsaw, Poland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-16
Primary Completion
2021-05-13
Completion
2021-05-13

Countries

  • Netherlands
  • Poland

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 NCT03334604 on ClinicalTrials.gov