Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants

Study Overview
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Brief Summary
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This study will assess the effect of partially hydrolyzed, whey-based infant formulas on growth and gastrointestinal tolerance in healthy term infants.

Official Title
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Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants: a Double-blind, Randomized, Controlled, Multi-arm Trial

Conditions
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Infant Nutritional Physiological Phenomena, Infant Formula, Infant Health, Infant Development, Growth and Development

Intervention / Treatment
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* Other: Control Formula
* Other: Experimental Formula 1
* Other: Experimental Formula 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Infant postnatal age ≤28 days (date of birth = day 0) Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk Infant's parent(s)/LAR is of legal age of majority, must understand the informed consent form and other relevant study documents, and is willing and able to fulfill the requirements of the study protocol Exclusion Criteria: 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 Infants with known (or symptoms suggestive of) cow's milk protein intolerance/allergy, or lactose intolerance or severe food allergies that impact diet Child has other medical or psychiatric condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study Currently participating or having participated in another interventional clinical trial prior to enrollment

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 28 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
Interventional Model Description: Double-blind, randomized, controlled, multi-arm trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control formula<br>CTRL, an infant formula with minimum protein content of 1.8g intact protein/100kcal | Other: Control Formula<br>* Infant formula made with intact protein - minimum 1.8g protein/100kcal<br>|
| Experimental: Experimental formula 1<br>EXPL1, an infant formula with minimum protein content of 1.9g hydrolyzed protein/100kcal | Other: Experimental Formula 1<br>* Infant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal<br>|
| Experimental: Experimental formula 2<br>EXPL2, an infant formula identical to EXPL1 but manufactured using a different partially hydrolyzed milk protein base | Other: Experimental Formula 2<br>* Infant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | From enrollment to age 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Enrollment and age 4, 6, and 12 months | 
| Stooling pattern | Stool frequency and consistency assessed using a 3-day infant stool diary. | 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. | 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. | Enrollment and age 4, 6, and 12 months | 
| Dietary intake | Total energy and macronutrient intake calculated from food recalls / diaries | Age 6 months | 
| Weight | Weight (g) | Enrollment and age 1, 2, 3, 4, and 6 months | 
| Length | Length (cm) | Enrollment and age 1, 2, 3, 4, and 6 months | 
| Head circumference | Head circumference (cm) | 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. | 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. | 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. | 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. | Enrollment and age 1, 2, 3, 4, and 6 months |