ASSESSMENT OF GROWTH OF INFANTS FED FORMULA WITH PROBIOTICS

Société des Produits Nestlé (SPN)8 sites in 1 countryDecember 2011

ConditionsHealthy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy
Sponsor: Société des Produits Nestlé (SPN)
Locations: 8
Primary Endpoint: growth
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a growth study of full-term, formula-fed infants randomized to receive a partially hydrolyzed whey protein formula with and without probiotics for the first four months of life. It is hypothesized that there will be no difference in growth between the two groups.

Registry

clinicaltrials.gov

Start Date

December 2011

End Date

October 2013

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Société des Produits Nestlé (SPN)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy newborn infant
•Full-term
•Birth weight \> 2500 and \< 4500 g
•14±3 days of age on enrollment
•Exclusively formula-fed, singleton birth
•Having obtained his/her legal representative's informed consent

Exclusion Criteria

•Known or suspected cow-milk allergy
•Congenital illness or malformation that may affect infant feeding and/or growth
•Significant prenatal and/or postnatal disease
•Any readmission to hospital prior to enrollment
•Receiving prescription medication or frequent use of over the counter medications except vitamin and mineral supplements
•Has received intravenous antibiotic therapy or oral probiotic in the last 7 days
•Currently participating in another clinical study
•Cannot be expected to comply with treatment