Safety Assessment of Lactobacillus Salivarius CECT5713 in 6 Months Old Children

Phase 1

Completed

• Conditions: Infection
• Interventions: Dietary Supplement: follow on formula without probiotics; Dietary Supplement: follow on formula with Lactobacillus salivarius CECT5713

• Registration Number: NCT00724204
• Lead Sponsor: Puleva Biotech

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2007-09
• Study Completion: 2007-12
• Status Verified: 2008-07
• Study First Submitted: 2008-07-28
• Study First Submitted QC: 2008-07-28
• Last Update Submitted: 2008-07-28
• Study First Posted: 2008-07-29
• Last Update Posted: 2008-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Healthy six months old children

Exclusion Criteria

• Lactose intolerance
• Cow's milk protein allergy
• Serious metabolic diseases
• Antibiotic treatment
• Serious gastrointestinal diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	follow on formula without probiotics	Children that consumed a follow on formula without Lactobacillus salivarius CECT5713
B	follow on formula with Lactobacillus salivarius CECT5713	Children that consumed a follow on formula with Lactobacillus salivarius CECT5713

Primary Outcome Measures

Name	Time	Method
Adverse reactions	3 months and 6 months

Secondary Outcome Measures

Name	Time	Method
growth parameters (height, length, head circumference)	3 months and 6 months
Fecal microbiota	3 months and 6 months
Fecal short chain fatty acids	3 months and 6 months

Trial Locations

Locations (1)

Hospital Universitario San Cecilio; 🇪🇸 Granada, Spain