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Safety Assessment of Lactobacillus Salivarius CECT5713 in 6 Months Old Children

NCT00724204 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2008-07-29

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Hospital Clinico Universitario San Cecilio

    collaborator OTHER

  • Puleva Biotech

    lead INDUSTRY

Principal Investigators

  • José A Maldonado, PhD, MD · Department of Pediatrics. Hospital Universitario San Cecilio

  • Mónica Olivares, PhD · Department of Nutrition and Health. Puleva Biotech. Granada

  • Federico Lara-Villoslada, PhD · Department of Nutrition and Helath. Puleva Biotech. Granada

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2007-09-30
Completion
2007-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT00724204 on ClinicalTrials.gov