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L Rhamnosus ATCC 53103 & L Reuteri DSM 29063 Compared With L Rhamnosus ATCC 53103 for Preventing AAD in Children

NCT04277156 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 892

Last updated 2020-02-20

No results posted yet for this study

Summary

This study will use a noninferiority design to examine whether the administration of L rhamnosus ATCC 53103 \& L reuteri DSM 29063 (Flostrum Baby) is no worse than (or as good as) the administration of a recommended probiotic L rhamnosus ATCC 53103 (commercially available as Dicoflor, hereafter a reference product) for the prevention of antibiotic-associated diarrhea in children,

Conditions

  • Antibiotic-associated Diarrhea

Interventions

DIETARY_SUPPLEMENT

Lactobacillus rhamnosus ATCC 53103 & Lactobacillus reuteri DSM 29063

7 drops contain Lactobacillus rhamnosus GG 5x10\^9 CFU; and Lactobacillus reuteri 1x10\^8 CFU.

DIETARY_SUPPLEMENT

L rhamnosus ATCC 53103

5 drops contain Lactobacillus rhamnosus 5x10\^9 CFU.

Sponsors & Collaborators

  • Adamed Pharma S.A.

    collaborator UNKNOWN

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Hanna Szajewska, MD · The Medical Univ of Warsaw, Dept of Paediatrics

  • Henryk Szymański, MD · Pediatric Department of St. Hedwig of Silesia Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-29
Primary Completion
2023-05-31
Completion
2023-12-31

Countries

  • 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 NCT04277156 on ClinicalTrials.gov