Infection
Conditions
Keywords
probiotics, safety, fecal microbiota, infections
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.
Interventions
DIETARY_SUPPLEMENTfollow on formula without probiotics
A follow on formula without probiotics
DIETARY_SUPPLEMENTfollow on formula with Lactobacillus salivarius CECT5713
follow on formula with Lactobacillus salivarius CECT5713 in a dose of 2x10E8 cfu/day
Sponsors
Hospital Clinico Universitario San Cecilio
Puleva Biotech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 6 Months
Healthy volunteers
Yes
Inclusion criteria
* Healthy six months old children
Exclusion criteria
* Lactose intolerance * Cow's milk protein allergy * Serious metabolic diseases * Antibiotic treatment * Serious gastrointestinal diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse reactions | 3 months and 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Spain
Outcome results
None listed