NCT00984230
Completed
N/A
A New Adaptive Feeding Plan for Newborns: Effects on Gut Maturity and Gut Microbiota
Société des Produits Nestlé (SPN)6 sites in 3 countries186 target enrollmentSeptember 2009
ConditionsInfant Nutrition
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Infant Nutrition
- Sponsor
- Société des Produits Nestlé (SPN)
- Enrollment
- 186
- Locations
- 6
- Primary Endpoint
- gut maturation : Specific proteins in stools
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
gut maturation : Specific proteins in stools
Time Frame: 3rd day, at 1 week, 2 weeks and 1 month of age
Secondary Outcomes
- Growth and gut microbiota(At 1 month and 2 months)
Study Sites (6)
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