Safety and Efficacy of a New Term Infant Formula Supplemented With A Prebiotic: a Doubleblind, Randomized, Controlled Trial

Société des Produits Nestlé (SPN)1 site in 1 country239 target enrollmentJanuary 21, 2016

ConditionsInfant Term Birth

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Infant Term Birth
Sponsor: Société des Produits Nestlé (SPN)
Enrollment: 239
Locations: 1
Primary Endpoint: Stool Consistency Score
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the experimental formula supplemented with a prebiotic vs the control formula.

Detailed Description

Randomized, double-blind, controlled interventional clinical trial design. The purpose of this study is to evaluate the safety and efficacy of a new term infant formula supplemented with a prebiotic vs a standard infant formula fed for 150 days to healthy, term infants.

Registry

clinicaltrials.gov

Start Date

January 21, 2016

End Date

May 2017

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Société des Produits Nestlé (SPN)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Written Informed Consent
•Infants whose parent(s)/LAR have reached the legal age of majority in the Philippines
•Infants whose parent(s)/LAR are willing and able to comply with study requirements
•Infants whose parent(s)/LAR are able to be contacted by telephone throughout the study
•Healthy term, singleton infant at birth
•Between 21 to 26 days post-natal age at enrollment visit
•Weight-for-length and head circumference-for-age z-scores \>/= - 3 and \</= +3 according to WHO Child Growth Standards
•Infants of parent(s)/LAR who have previously made the decision to formula feed their infant at the time of enrollment

Exclusion Criteria

•Infants with conditions requiring infant feedings other than those specified in the protocol
•Infants receiving complementary foods or liquids
•Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results
•Infants who are presently receiving or have received medications that could interfere with the interpretation of study results
•Infants or infants whose parents/LAR cannot be expected to comply with the protocol or with study procedures