Effects of an Infant Formula on Growth, Safety and Efficacy for Healthy Term Infants

Bunge Loders Croklaan

Status: Completed

Conditions: Infant Development

Treatments: Other: Study Formula

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04749290

20-SM-09-Bunge-001

Details and patient eligibility

About

The purpose of this study is to evaluate that a Cow's Milk Based Infant Formula A2 Containing Both OPO and CPP for healthy term infants supports age-appropriate growth. In this randomized, controlled trial (RCT), healthy, term, formula-fed (FF) infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants (CF) or the study formula for term infants (SF) for 16 weeks. A reference group of human milk-fed infants will also be enrolled. The primary objective is to compare the growth, tolerance, stool consistency and bone strength of infants randomized to the study infant formula (SF) versus infants randomized to the standard commercial infant formula (CF).

Full description

This study is a randomized, controlled, double-blind, study of healthy term formula fed (FF) infants. FF infants will be randomized to receive either a study infant formula, formulated for healthy term infants or a commercially available infant formula for healthy term infants. Infants will consume the formula for a total of 16-weeks; infant growth, tolerance, stool consistency and bone strength will be assessed throughout the study.

Enrollment: 180 patients

Sex: All

Ages: 14 to 30 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 30 days of age at randomization, inclusive (day of birth is considered day 0)
• Exclusively formula-fed or partially bottle feeding with intake more than 650 ml /day for at least 3 days prior to randomization
• Exclusively breast fed for at least 7 days prior to randomization
• Singleton birth
• Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks of gestational age)
• Birth weight of 2500g to 4000g
• Signed informed consent obtained for infant's participation in the study
• Parent or guardian of infant agrees not to enroll infant in another interventional clinical research study while participating in this study

Exclusion criteria

• History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant
• Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion)
• Weight at Visit 1 is <95% of birth weight [(weight at Visit 1÷birth weight) x 100 <95%]
• Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others) and children with known head/brain disease/injury such as Microcephaly, Macrocephaly or others
• Participation in another clinical trial
• Known or increased risk of cow's milk allergy and/ or lactose intolerance (i.e. one of the biological parents and or siblings diagnosed with cow's milk allergy, asthma, hay fever, etc.)
• Having a mother suffering from diabetes during pregnancy
• Use of antibiotics at the time of screening, or during the past two weeks

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 3 patient groups

Study Formula

Experimental group

Description:

a Cow's Milk Based Infant Formula Containing Both OPO and CPP for term infants (JunLeBao ZhiZhen)

Treatment:

Other: Study Formula

Comparator Formula

Active Comparator group

Description:

Commercially available infant formula without OPO for term infants (JunLeBao LeChun)

Treatment:

Other: Study Formula

Human Milk Reference Group

No Intervention group

Description:

Human milk