Effect of a Follow on Formula With Lactobacillus Fermentum on the Incidence of Infections
Phase 2
Completed
- Conditions
- Incidence of Infectious Diseases
- Registration Number
- NCT01215656
- Lead Sponsor
- Puleva Biotech
- Brief Summary
The objective of the study is to evaluate the effects of a follow on formula containing the human milk probiotic Lactobacillus fermentum on the incidence of infection in 6 months old infants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 188
Inclusion Criteria
- 6 months old children born at term
- written consent from parents
Exclusion Criteria
- frequent gastrointestinal disorders (frequent diarrhoeas, constipation episodes, gastroesophageal reflux)
- gastrointestinal surgery
- cow's milk protein allergy
- metabolic diseases (diabetes or lactose intolerance)
- immune deficiency
- antibiotic treatment during the trial and/or recent (within the preceding 3 weeks)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of infectious diseases
- Secondary Outcome Measures
Name Time Method