Study Evaluating Growth and Tolerance of Infant Formula Containing HMOs

Jennewein Biotechnologie GmbH340 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

340

Conditions

Infant Nutrition

Interventions

human milk oligosaccharidesDIETARY_SUPPLEMENT

mixture of five different human milk oligosaccharides

Eligibility

Sex: ALLMin age: 1 DayMax age: 13 DaysHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (9)

Facharzt für Kinder und Jugendmedizin

Mannheim, Germany

Klinikum Südstadt Rostock

Rostock, Germany

ASST Spedali Civili di Brescia - Presidio Ospedale dei Bambini

Brescia, Italy

Ospedale San Raffaele

Milan, Italy

Outcomes

Primary Outcomes

assessment of body weight (in grams) of term infants

growth, assessed by body weight gain, of term infants from enrollment to 4 month of life

Time frame: 4 month

Secondary Outcomes

assessment of body length (in centimeter) of term infants

growth, assessed as body length, of term infants from enrollment to 4 month of life

Time frame: 4 month

assessment of head circumference (in centimeter) of term infants

growth, assessed as head circumference, of term infants from enrollment to 4month of life

Time frame: 4 month

Data from ClinicalTrials.gov

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