Happy Smooth Study

Nestlé

Status

Completed

Conditions

Infant Term Birth

Treatments

Other: Standard Infant Formula

Other: Experimental Infant Formula

Study type

Interventional

Funder types

Industry

Identifiers

NCT03710551

16.28.INF

Details and patient eligibility

About

The purpose of this study is to evaluate the stool composition and GI tolerance of an experimental formula with a new fat blend plus L. reuteri vs control formula.

Full description

Double-blind, randomized, controlled clinical trial. The purpose of this study is to evaluate the stool composition and GI tolerance of 140 healthy, term infants fed with an infant formula with a new fat blend plus L. reuteri vs a standard infant formula. All enrolled infants will participate in the trial for approximately 71 days.

Enrollment

140 patients

Sex

All

Ages

21 to 28 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Written Informed Consent
Infants whose parents/LAR have reached the legal age of majority in the Philippines
Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol
Infants whose parent(s)/LAR are able to be contacted directly by telephone throughout the study
Healthy term, singleton infant at birth
Between 21 to 28 days post-natal age at enrollment visit
Weight-for-age ≥ 5th and ≤ 95th percentile according to World Health Organization growth tables/charts
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 the study results