Study Evaluating Growth and Tolerance of Infant Formula Containing HMOs

Study Overview
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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.

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.

Official Title
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Evaluation of Nutritional Suitability and Tolerability of a Human Milk Oligosaccharide (HMO) Mix in Infant Formula for Term Infants

Conditions
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Infant Nutrition

Intervention / Treatment
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* Dietary Supplement: human milk oligosaccharides


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 13 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: infant formula containing five HMOs<br> | Dietary Supplement: human milk oligosaccharides<br>* mixture of five different human milk oligosaccharides<br>|
| No Intervention: infant formula<br> | |
| No Intervention: breast milk group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 4 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of body length (in centimeter) of term infants | growth, assessed as body length, of term infants from enrollment to 4 month of life | 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 | 4 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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human milk oligosaccharides, infant formula