Efficacy of a New Infant Formula Composition on Gut Health in Infants

FrieslandCampina

Status

Not yet enrolling

Conditions

Healthy Infants

Treatments

Other: Infant Formula

Other: Infant Formula with bioactive ingredients

Study type

Interventional

Funder types

Industry

Identifiers

NCT07242508

ECCT2831

Details and patient eligibility

About

The aim of this study is to investigate potential health benefits of the experimental formula. The main objective is whether the experimental formula elevates the relative abundance of Bifidobacterium in stool samples after 10 weeks, as compared a standard formula, aka control formula. In addition other markers of gut health, such as stool characteristics, and gut health symptoms will be monitored

Enrollment

120 estimated patients

Sex

All

Ages

Under 3 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy, full term, infants with a birth weight between 2500-4500 grams
Parents independently from study decided to not breastfeed their infant
Parents agree to feed the assigned study formula as the infant's sole source of nutrition for the duration of the study
have read and voluntarily signed an informed consent form
parents are capable of completing study procedures required by the protocol

Exclusion criteria

suffering from any anatomic and/or physiologic condition that would interfere with normal growth, development or feeding
are required to take medications or supplements known to influence growth and development
have a maternal history with known adverse effects on the fetus and/or the newborn infant
have previous or current antibiotics use (antibiotics administered during delivery are permitted)
have received or are planning to receive probiotics, prebiotics, or nutritional supplements prior to and throughout the trial (excluding vitamin D and vitamin K supplementation)
personal history of or parents/siblings diagnosed with cow's milk protein allergy or lactose intolerance
multiple birth
participation in another trial