This study will assess the effect of partially hydrolyzed, whey-based infant formulas on growth and gastrointestinal tolerance in healthy term infants.
Written informed consent has been obtained from at least one parent (or other legally acceptable representative [LAR]), if applicable)
Infant gestational age ≥37 completed weeks
Infant birth weight of ≥2.5 kg and ≤4.5 kg
Singleton birth
Chronic infectious, metabolic, genetic illness or other disease, including any condition that impacts feeding or growth
Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis)
Maternal medical conditions known to affect infant growth (e.g., untreated preeclampsia or gestational diabetes)
Infants with special dietary needs other than standard infant formula
Parallel
Control Formula
Other interventionInfant formula made with intact protein - minimum 1.8g protein/100kcal
Experimental Formula 1
Other interventionInfant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal
Experimental Formula 2
Other interventionInfant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal
Difference in growth in first 4 months of life between control and experimental groups
To demonstrate that growth from enrollment to age 4 months of infants fed experimental formula 1 (EXPL1) or experimental formula 2 (EXPL2) is non-inferior to that of infants fed control formula (CTRL). This is measured by weight gain velocity (g/day).
Equivalence in growth in first 4 months of life in experimental groups
To demonstrate that growth from enrollment to age 4 months is equivalent between infants fed EXPL1 or EXPL2. This is measured by weight gain velocity (g/day).
Gastrointestinal (GI) tolerance
GI tolerance assessed using the Infant Gastrointestinal Symptom Questionnaire (IGSQ). IGSQ scores range from 13 to 65, with lower scores indicating lower GI symptom burden.
Stooling pattern
Stool frequency and consistency assessed using a 3-day infant stool diary.
Atopic dermatitis severity
Atopic dermatitis severity assessed using the Patient Oriented Eczema Measure (POEM). POEM scores range from 0 to 28, with lower scores indicating lower atopic dermatitis severity.
Allergy-related symptoms
Allergy-related symptoms assessed using the Multi-Organ System Questionnaire for Infants (MOSQ-I). MOSQ-I scores range from 0 to 105, with lower scores indicating lower allergy-related symptom burden.
Stool microbiota composition
Stool microbiota composition assessed using shotgun metagenomic analysis
Stool microbiota metabolism
Stool organic acids and other metabolites
Fecal peptides
Fecal milk-derived peptides
Urinary metabolomic profile
Untargeted analysis of urine metabolites by H1-nuclear magnetic resonance (NMR) spectroscopy
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