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Clinical Trials/NCT00984230
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

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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
February 2011
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Société des Produits Nestlé (SPN)
Responsible Party
Sponsor

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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