Infant Nutritional Physiological Phenomena, Infant Formula, Infant Health, Infant Development, Growth and Development
Conditions
Brief summary
This study will assess the effect of partially hydrolyzed, whey-based infant formulas on growth and gastrointestinal tolerance in healthy term infants.
Interventions
OTHERControl Formula
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
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Double-blind, randomized, controlled, multi-arm trial
Eligibility
Sex/Gender
ALL
Age
0 Days to 28 Days
Healthy volunteers
Yes
Inclusion criteria
1. Written informed consent has been obtained from at least one parent (or other legally acceptable representative \[LAR\]), if applicable) 2. Infant gestational age ≥37 completed weeks 3. Infant birth weight of ≥2.5 kg and ≤4.5 kg 4. Singleton birth 5. Infant postnatal age ≤28 days (date of birth = day 0) 6. Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk 7. 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
1. Chronic infectious, metabolic, genetic illness or other disease, including any condition that impacts feeding or growth 2. Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis) 3. Maternal medical conditions known to affect infant growth (e.g., untreated preeclampsia or gestational diabetes) 4. Infants with special dietary needs other than standard infant formula 5. Infants with known (or symptoms suggestive of) cow's milk protein intolerance/allergy, or lactose intolerance or severe food allergies that impact diet 6. Child has other medical or psychiatric condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study 7. Currently participating or having participated in another interventional clinical trial prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Equivalence in growth in first 4 months of life in experimental groups | From enrollment to age 4 months | 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). |
| Difference in growth in first 4 months of life between control and experimental groups | From enrollment to age 4 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stooling pattern | Age 2 and 4 months | Stool frequency and consistency assessed using a 3-day infant stool diary. |
| Atopic dermatitis severity | Enrollment and age 4, 6, and 12 months | 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 | Enrollment and age 4, 6, and 12 months | 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. |
| Dietary intake | Age 6 months | Total energy and macronutrient intake calculated from food recalls / diaries |
| Weight | Enrollment and age 1, 2, 3, 4, and 6 months | Weight (g) |
| Head circumference | Enrollment and age 1, 2, 3, 4, and 6 months | Head circumference (cm) |
| Weight-for-age z-score | Enrollment and age 1, 2, 3, 4, and 6 months | Weight-for-age z-score based on World Health Organization (WHO) and Saudi Arabian growth charts. |
| Length | Enrollment and age 1, 2, 3, 4, and 6 months | Length (cm) |
| Length-for-age z-score | Enrollment and age 1, 2, 3, 4, and 6 months | Length-for-age z-score based on World Health Organization (WHO) and Saudi Arabian growth charts. |
| Head circumference-for-age z-score | Enrollment and age 1, 2, 3, 4, and 6 months | Head circumference-for-age z-score based on World Health Organization (WHO) and Saudi Arabian growth charts. |
| Weight-for-length z-score | Enrollment and age 1, 2, 3, 4, and 6 months | Weight-for-length z-score based on World Health Organization (WHO) and Saudi Arabian growth charts. |
| Gastrointestinal (GI) tolerance | Enrollment and age 4, 6, and 12 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fecal peptides | Age 4 months | Fecal milk-derived peptides |
| Urinary metabolomic profile | Age 4 months | Untargeted analysis of urine metabolites by H1-nuclear magnetic resonance (NMR) spectroscopy |
| Stool microbiota metabolism | Age 4 months | Stool organic acids and other metabolites |
| Stool microbiota composition | Age 4 months | Stool microbiota composition assessed using shotgun metagenomic analysis |
Countries
Saudi Arabia
Contacts
Primary ContactAnthony de Cozar
Outcome results
None listed