Study Evaluating Growth and Tolerance of Infant Formula Containing HMOs

Jennewein Biotechnologie

Status

Completed

Conditions

Infant Nutrition

Treatments

Dietary Supplement: human milk oligosaccharides

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT03513744

JEN/008017

Details and patient eligibility

About

The primary objective of this clinical study is to investigate the suitability of an infant formula containing five different human milk oligosaccharides to support normal physical growth (evaluated per weight gain), in comparison with infant formula without human milk oligosaccharides, when the formula is fed as the sole source of nutrition.

Full description

The main goal of the study is to investigate the suitability of an infant formula containing five different human milk oligosaccharides to support normal physical growth of term infants (evaluated per weight gain, body length and head circumference), in comparison with infant formula without human milk oligosaccharides, when the formula is fed exclusivly in the first four month of life. Additionally, a comparison of the two formula fed groups against a reference group with breastfed infants as well as the WHO growth standard reference tables will be performed. An assessment of safety and tolerability will be performed as well.

As a secondary out come of the study, we will examine the effect of the formula on the infant microbiome, as well as the HMO status of the mother's milk towards the microbial composition of the infant microbiome.

Enrollment

340 patients

Sex

All

Ages

1 to 13 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Singleton birth
Full-term infant (37 - 42 weeks of gestational age)
APGAR score of 9 or 10
Birth weight 2500 - 4500 g

Exclusion criteria

clinically significant condition/ disorder
Adverse maternal of fetal medical history that may influence growth/development of the subject or tolerance of the infant formula
readmission to hospital (except for hyperbilirubinemia)
allergy to cow's milk
participation in another study