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Safety Assessment of Lactobacillus Salivarius CECT5713 in 6 Months Old Children — P010  

Infection Clinical Trial

Official title:
Functional Evaluation of a Follow on Formula Supplemented With Lactobacillus Salivarius CECT5713

Clinical Trial Summary

The aim of the trial is to evaluate safety of a follow on formula supplemented with Lactobacillus salivarius CECT5713. A randomized double blind placebo controlled trial was carried out. Eighty six months old children were recruited by the department of pediatrics of Hospital Univeristario San Cecilio. Children were divided in two groups that consumed a follow on formula supplemented or not with the probiotic strain during 6 months. Fecal samples were obtained at the recruitment, at 3 months and at the end of the trial. In addition revision by the pediatrician was performed once a month and possible adverse effects were recorded both by the pediatrician and by parents.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00724204
Study type Interventional
Source Puleva Biotech
Contact
Status Completed
Phase Phase 1
Start date April 2006
Completion date December 2007
View Details
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