Safety and Efficacy Study

Nestlé

Status

Completed

Conditions

Infant Term Birth

Treatments

Other: Standard Infant Formula

Other: Experimental Infant Formula

Study type

Interventional

Funder types

Industry

Identifiers

NCT02670863

14.15.INF

Details and patient eligibility

About

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

Full 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.

Enrollment

239 patients

Sex

All

Ages

21 to 26 days old

Volunteers

Accepts Healthy Volunteers

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