Safety Assessment of Lactobacillus Salivarius CECT5713 in 6 Months Old Children
Phase 1
Completed
- Conditions
- Infection
- 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
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
- 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
Hospital Universitario San Cecilio🇪🇸Granada, Spain