Growth of Infants Fed a New Term Infant Formula

Study Overview
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Brief Summary
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To evaluate the growth of healthy term infants fed an experimental infant formula with a prebiotic, a commercial control infant formula with a probiotic, but without a prebiotic and human breast milk

Detailed Description
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Multisite, double-blind, randomized, controlled clinical trial. The purpose of the study is to determine if infants fed a standard infant formula with a prebiotic have a weight gain in line with infants fed a standard starter infant formula without a prebiotic.

Official Title
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Growth of Infants Fed a New Term Infant Formula With a Prebiotic

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Infant formula (CF)
* Dietary Supplement: Infant Formula (EF)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent signed and dated Infants whose parent(s)/Legally Authorized Representative (LAR) have reached the legal age of majority in Belgium Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol. Infants whose parent(s)/LAR are able to be contacted directly by telephone throughout the study. Infants whose parent(s)/LAR have a working freezer. Healthy term, singleton infant at birth. At enrollment visit, post-natal age ≤ 14 days (date of birth = day 0). At enrollment, birth weight ≥ 2500g and ≤ 4500g. For formula-fed group, infant of parent(s)/LAR who have previously made the decision to formula feed their infant at the time of enrollment. Exclusion Criteria: Infants with conditions requiring infant feedings other than those specified in the protocol. Infants receiving complementary foods or liquids. Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results. Infants who are presently receiving or have received prior to enrollment medications that could interfere with the interpretation of study results. Infants or infants whose parent(s)/LAR who in the Investigator's assessment cannot be expected to comply with the protocol or with study procedures.

Ages Eligible for Study
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Maximum Age: 14 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo comparator (Control)<br>Starter infant formula with a probiotic and without a prebiotic. Volumes of feed depend on age, weight and appetite. | Dietary Supplement: Infant formula (CF)<br>* Formula-fed infants will be randomly assigned to receive one of the study formulas (CF or EF) orally, ad libitum, each day from Study Day 1 until Study Day 180, for a treatment duration of approximately 180 days.<br>|
| Experimental: Experimental Formula (Test)<br>Starter infant formula with a probiotic and prebiotic. Volumes of feed depend on age, weight and appetite. | Dietary Supplement: Infant Formula (EF)<br>* Formula-fed infants will be randomly assigned to receive one of the study formulas (CF or EF) orally, ad libitum, each day from Study Day 1 until Study Day 180, for a treatment duration of approximately 180 days.<br>|
| No Intervention: Breastfed reference group<br>Breastfed reference group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth | Growth (weight gain velocity) | 120 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth | Other growth outcomes will be compared to the World Health Organization 2006 Growth Standards and by treatment group | Every month up to 6 months of age | 
| Stool patterns (3-day GI symptom and behavior diary - stool frequency and stool consistency) | Stool patterns (3-day GI symptom and behavior diary - stool frequency and stool consistency) | Every month up to 6 months of age | 
| GI tolerance (3-day GI symptom and behavior diary - including GI symptoms, GI-related behaviors, and milk intake) | GI tolerance (3-day GI symptom and behavior diary - including GI symptoms (frequency and amount of spitting-up/vomiting, and frequency of flatulence), GI-related behaviors (duration of crying and fussiness, sleeping, and the frequency of excessive crying episodes), and milk intake) | Every month up to 6 months of age | 
| Fecal microbiota composition and diversity (16S rRNA sequencing and qPCR) | Fecal microbiota composition, diversity, and abundance | Every month up to 4 months of age | 
| Fecal markers (pH, fecal organic acids, and protein markers of gut health) | Fecal markers (pH, fecal organic acids, and protein markers of gut health) | Every month up to 4 months of age | 
| Gene expression (infant exfoliated and microbial cell gene expression by shotgun sequencing) | Gene expression (infant exfoliated and microbial cell gene expression by shotgun sequencing) | Up to 3 months of age | 
| Adverse events / Morbidity | Adverse events / Morbidity | 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy babies, Infant formula, Growth