Study Evaluating Growth and Tolerance of Infant Formula Containing HMOs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-19

Study Completion Date

2021-04-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infant Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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infant formula containing five HMOs

Group Type EXPERIMENTAL

human milk oligosaccharides

Intervention Type DIETARY_SUPPLEMENT

mixture of five different human milk oligosaccharides

infant formula

Group Type NO_INTERVENTION

No interventions assigned to this group

breast milk group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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human milk oligosaccharides

mixture of five different human milk oligosaccharides

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

1 Day

Maximum Eligible Age

13 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes