Tolerance
Conditions
Keywords
Probiotic, infant nutrition, safety, infections
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.
Interventions
OTHERInfant formula
Powder infant formula
Sponsors
Puleva Biotech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Days to 30 Days
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| average weight gain | 4 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Spain
Outcome results
None listed