Clinical trial NCT03513744: Study Evaluating Growth and Tolerance of Infant Formula Containing HMOs
Official title: Evaluation of Nutritional Suitability and Tolerability of a Human Milk Oligosaccharide (HMO) Mix in Infant Formula for Term Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Nutrition
Keywords: human milk oligosaccharides
infant formula
Lead sponsor: Jennewein Biotechnologie GmbH
Sponsor class: INDUSTRY
Collaborators: name: Analyze & Realize
First posted: 2018-05-02
Enrollment: 340
Sex: ALL
Minimum age (years): 1
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: assessment of body weight (in grams) of term infants
timeFrame: 4 month
Secondary outcomes:
measure: assessment of body length (in centimeter) of term infants
timeFrame: 4 month
measure: assessment of head circumference (in centimeter) of term infants
timeFrame: 4 month
Other outcomes:
measure: digestive tolerance
timeFrame: 4 month
measure: influence of digestion
timeFrame: 4 month
measure: influence on behaviour
timeFrame: 4 month
measure: product compliance
timeFrame: 4 month
measure: morbidity
timeFrame: 4 month
measure: stool microbiota
timeFrame: 4 month
measure: HMO composition in breast milk
timeFrame: 4 month
Locations:
city: Mannheim
country: Germany
facility: Facharzt für Kinder und Jugendmedizin
city: Rostock
country: Germany
facility: Klinikum Südstadt Rostock
city: Brescia
country: Italy
facility: ASST Spedali Civili di Brescia - Presidio Ospedale dei Bambini
city: Milan
country: Italy
facility: Ospedale San Raffaele
city: Madrid
country: Spain
facility: Hospital HM Puerta del Sur
city: Madrid
country: Spain
facility: Hospital HM Monteprincipe
city: Madrid
country: Spain
facility: Hospital HM Nuevo Belen
city: Reus
country: Spain
facility: Hospital Universitario Sant Joan de Reus
city: Tarragona
country: Spain
facility: Hospital Joan XXII of Tarragona
Study officials:
affiliation: Universitaetsmedizin Berlin, Charité
name: Frank Jochum, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: