Trial | NCT00724204  Report issue

Title

Safety Assessment of Lactobacillus Salivarius CECT5713 in 6 Months Old Children
Functional Evaluation of a Follow on Formula Supplemented With Lactobacillus Salivarius CECT5713

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    lactobacillus salivarius ...

  • Study Participants

    80
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.
Study Started
Apr 30
2006
Primary Completion
Sep 30
2007
Study Completion
Dec 31
2007
Last Update
Jul 29
2008
Estimate

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

A Placebo Comparator

Children that consumed a follow on formula without Lactobacillus salivarius CECT5713

B Active Comparator

Children that consumed a follow on formula with Lactobacillus salivarius CECT5713

Criteria 

Inclusion Criteria:

Healthy six months old children

Exclusion Criteria:

Lactose intolerance
Cow's milk protein allergy
Serious metabolic diseases
Antibiotic treatment
Serious gastrointestinal diseases
No Results Posted