Clinical Safety of a New Infant Starter Formula Containing 2 Human Milk Oligosaccharides (HMOs)

Société des Produits Nestlé (SPN)2 sites in 2 countries176 target enrollmentOctober 2012

ConditionsHealthy

Overview

Phase: N/A
Intervention: Not specified
Conditions: Healthy
Sponsor: Société des Produits Nestlé (SPN)
Enrollment: 176
Locations: 2
Primary Endpoint: Growth
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this clinical study is to show that infants fed a standard starter infant formula with 2 Human Milk Oligosaccharides (HMOs) have a growth in line with infants fed a standard starter infant formula without HMOs.

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

July 2015

Last Updated

10 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 babies
•Full term babies (37 weeks ≤ gestation ≤ 42 weeks)
•birth weight between 2500 g- 4500g
•Having obtained the baby's legal representative's informed consent.
•FF groups:
•babies aged between birth and 14 days, exclusively formula-fed at time of enrollment, whose mother independently elected, before enrollment, not to breastfeed
•BF group: babies aged 3 months (+/- 5 days), exclusively breastfed since birth.

Exclusion Criteria

•Congenital illness or malformation that may affect growth
•Significant pre-natal and/or serious post-natal disease before enrollment (by medical decision)
•Minor parent(s)
•Newborn whose parents / caregivers cannot be expected to comply with study procedures
•Currently participating or having participated in another clinical trial since birth, except for BF group, where vaccines studies are allowed.

Outcomes

Primary Outcomes

Growth

Time Frame: 4 months of life

child growth (body weight) from enrollment to 4 months of age

Secondary Outcomes

Growth(6 and 12 months of age)
Digestive tolerance (stool charecteristics, bowel movements,behavior patterns)(every month during 6 months)
Stool microbiota(3 and 12 months of age)
Gene expression(3 and 12 months of age)
Product compliance (quantity of formula in ml consumed on the 3 days before visit)(every month for 6 months)
Morbidity(ongoing for 1 year)