Clinical Safety of a New Infant Starter Formula Containing 2 Human Milk Oligosaccharides (HMOs)

Study Overview
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Brief Summary
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The primary objective of this clinical study is to show that infants fed a standard starter infant formula with 2 Human Milk Oligosaccharides (HMOs) have a growth in line with infants fed a standard starter infant formula without HMOs.

Official Title
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Clinical Safety of a New Infant Starter Formula Containing 2 Human Milk Oligosaccharides (HMOs)

Conditions
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Healthy

Intervention / Treatment
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* Other: Infant Formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy babies Full term babies (37 weeks ≤ gestation ≤ 42 weeks) birth weight between 2500 g- 4500g Having obtained the baby's legal representative's informed consent. FF groups: babies aged between birth and 14 days, exclusively formula-fed at time of enrollment, whose mother independently elected, before enrollment, not to breastfeed • BF group: babies aged 3 months (+/- 5 days), exclusively breastfed since birth. Exclusion Criteria: Congenital illness or malformation that may affect growth Significant pre-natal and/or serious post-natal disease before enrollment (by medical decision) Minor parent(s) Newborn whose parents / caregivers cannot be expected to comply with study procedures Currently participating or having participated in another clinical trial since birth, except for BF group, where vaccines studies are allowed.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Starter infant formula without HMO<br>Volumes of feed depend on age, weight and appetite. | Other: Infant Formula<br> <br> |
| Active Comparator: Starter infant formula with 2 HMOs<br>Volumes of feeds depend on age, weight and appetite | Other: Infant Formula<br> <br> |
| No Intervention: Breasfed reference group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth | child growth (body weight) from enrollment to 4 months of age | 4 months of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth |  | 6 and 12 months of age | 
| Digestive tolerance (stool charecteristics, bowel movements,behavior patterns) | Parents are asked to complete a diary on digistive tolerance of their child | every month during 6 months | 
| Product compliance (quantity of formula in ml consumed on the 3 days before visit) | Parents are asked to complete a diary on the product compliance | every month for 6 months | 
| Morbidity |  | ongoing for 1 year | 
| Stool microbiota |  | 3 and 12 months of age | 
| Gene expression |  | 3 and 12 months of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy babbies, infant formula, growth, HMO