NCT00724204

Safety Assessment of Lactobacillus Salivarius CECT5713 in 6 Months Old Children

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Puleva Biotech · Industry
• Sex: All
• Age: 6 Months – 6 Months
• Healthy volunteers: Accepted

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.

Conditions

• Infection

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	follow on formula without probiotics	A follow on formula without probiotics
DIETARY_SUPPLEMENT	follow on formula with Lactobacillus salivarius CECT5713	follow on formula with Lactobacillus salivarius CECT5713 in a dose of 2x10E8 cfu/day

Timeline

• Start date: 2006-04-01
• Primary completion: 2007-09-01
• Completion: 2007-12-01
• First posted: 2008-07-29
• Last updated: 2008-07-29

Locations

1 site across 1 country: Spain