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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control formula | Active Comparator | CTRL, an infant formula with minimum protein content of 1.8g intact protein/100kcal |
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| Experimental formula 1 | Experimental | EXPL1, an infant formula with minimum protein content of 1.9g hydrolyzed protein/100kcal |
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| Experimental formula 2 | Experimental | EXPL2, an infant formula identical to EXPL1 but manufactured using a different partially hydrolyzed milk protein base |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Formula | Other | Infant formula made with intact protein - minimum 1.8g protein/100kcal |
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Stool microbiota composition | Stool microbiota composition assessed using shotgun metagenomic analysis | Age 4 months |
| Stool microbiota metabolism | Stool organic acids and other metabolites |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anthony de Cozar | Contact | +41 21 785 8573 | anthony.decozar@rd.nestle.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Guard Hospital | Recruiting | Jeddah | Saudi Arabia |
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Double-blind, randomized, controlled, multi-arm trial
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| Experimental Formula 1 | Other | Infant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal |
|
| Experimental Formula 2 | Other | Infant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal |
|
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 |
| Age 4 months |
| Fecal peptides | Fecal milk-derived peptides | Age 4 months |
| Urinary metabolomic profile | Untargeted analysis of urine metabolites by H1-nuclear magnetic resonance (NMR) spectroscopy | Age 4 months |
| King Faisal Specialist Hospital and Research Center | Completed | Riyadh | Saudi Arabia |
| National Guard Hospital | Active, not recruiting | Riyadh | Saudi Arabia |