Infant Nutrition
Conditions
Keywords
Infant Formula, Gut
Brief summary
The purpose of this clinical trial is to identify the infant formula(s) for which the investigators get the closest gut maturation index compared to the one they get with breastfed babies.
Interventions
OTHERBSF
feeding amount according to individual baby need
OTHERBSF + Lactoferrin + Probiotics
feeding amount according to individual baby need
OTHERBSF + Lactoferrin + Probiotics + OS
feeding amount according to individual baby need
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 3 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy newborn infant * Full term infant (≥ 37 weeks gestation; \< 42 weeks gestation) * Birth weight from 2500g to 4500g * For the formula-fed groups: babies whose mothers elected not to breastfeed at all * For the breastfed group: babies whose mothers elected to exclusively breastfeed for at least 2 months * Newborn whose parents / caregivers can be expected to comply with the protocol * Study explained and written information given * Informed consent signed
Exclusion criteria
* Mother who had antibiotics in the 7 days preceding delivery * Caesarian section * Multiple birth * Congenital illness or malformation that may affect normal growth * Significant pre-natal and/or post-natal disease * Newborn participating in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| gut maturation : Specific proteins in stools | 3rd day, at 1 week, 2 weeks and 1 month of age |
Secondary
| Measure | Time frame |
|---|---|
| Growth and gut microbiota | At 1 month and 2 months |
Countries
Austria, France, Greece
Outcome results
None listed