Safety of Lactobacillus Fermentum in Newborn Infants
Not Applicable
Completed
- Conditions
- Tolerance
- Interventions
- Other: Infant formula
- Registration Number
- NCT01346644
- Lead Sponsor
- Puleva Biotech
- Brief Summary
In the last years manipulation of intestinal microbiota with probiotics has gained an increasing interest, specially in infant nutrition since recent studies has demonstrated the presence of probiotics in human milk. However, there are few studies studying the effects of probiotics in newborns. The objective of the present study is to analyze safety and tolerance of the probiotic Lactobacillus fermentum CECT5716 isolated from human milk.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 137
Inclusion Criteria
- Healthy 1 month infants exclusively formula-fed
Exclusion Criteria
- gastrointestinal disorders (history of chronic diarrhoea or constipation, gastroesophageal reflux)
- gastrointestinal surgery
- cow's milk protein allergy
- metabolic disorders (diabetes, lactose intolerance)
- immune deficiency
- antibiotic prescription 1-week prior to inclusion and previous use of formula containing prebiotics or probiotics
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description No probiotics Infant formula Infant formula with no probiotics Probiotic Infant formula Infant formula supplemented with probiotic
- Primary Outcome Measures
Name Time Method average weight gain 4 months
- Secondary Outcome Measures
Name Time Method growth and health of infants 2,4,6,12 and 36 months of life average weight, length of infants. Incidence of infections. Incidence of allergic diseases
Trial Locations
- Locations (1)
Biosearch Life
🇪🇸Granada, Spain