This study will assess the effect of partially hydrolyzed, whey-based infant formulas on growth and gastrointestinal tolerance in healthy term infants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
234
Infant formula made with intact protein - minimum 1.8g protein/100kcal
Infant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal
Infant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal
National Guard Hospital
Jeddah, Saudi Arabia
RECRUITINGKing Faisal Specialist Hospital and Research Center
Riyadh, Saudi Arabia
COMPLETEDNational Guard Hospital
Riyadh, Saudi Arabia
ACTIVE_NOT_RECRUITINGDifference 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).
Time frame: From enrollment to age 4 months
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).
Time frame: From enrollment to age 4 months
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.
Time frame: Enrollment and age 4, 6, and 12 months
Stooling pattern
Stool frequency and consistency assessed using a 3-day infant stool diary.
Time frame: Age 2 and 4 months
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.
Time frame: Enrollment and age 4, 6, and 12 months
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.
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Time frame: Enrollment and age 4, 6, and 12 months
Dietary intake
Total energy and macronutrient intake calculated from food recalls / diaries
Time frame: Age 6 months
Weight
Weight (g)
Time frame: Enrollment and age 1, 2, 3, 4, and 6 months
Length
Length (cm)
Time frame: Enrollment and age 1, 2, 3, 4, and 6 months
Head circumference
Head circumference (cm)
Time frame: Enrollment and age 1, 2, 3, 4, and 6 months
Weight-for-age z-score
Weight-for-age z-score based on World Health Organization (WHO) and Saudi Arabian growth charts.
Time frame: Enrollment and age 1, 2, 3, 4, and 6 months
Weight-for-length z-score
Weight-for-length z-score based on World Health Organization (WHO) and Saudi Arabian growth charts.
Time frame: Enrollment and age 1, 2, 3, 4, and 6 months
Length-for-age z-score
Length-for-age z-score based on World Health Organization (WHO) and Saudi Arabian growth charts.
Time frame: Enrollment and age 1, 2, 3, 4, and 6 months
Head circumference-for-age z-score
Head circumference-for-age z-score based on World Health Organization (WHO) and Saudi Arabian growth charts.
Time frame: Enrollment and age 1, 2, 3, 4, and 6 months