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

RecruitingNAAges 0 Days - 28 DaysAllSociété des Produits Nestlé (SPN)
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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. For Saudi: Infant postnatal age ≤28 days (date of birth = day 0); For Philippines: Infant postnatal age ≥ 14 days and ≤ 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
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What it tests

  • Control Formula
  • Experimental Formula 1
  • Experimental Formula 2
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Where

5 sites
Biomedical Research Institute
Cavite City, Philippines
Biomedical Research Institute
Las Piñas, Philippines
National Guard Hospital
Jeddah, Saudi Arabia
King Faisal Specialist Hospital and Research Center
Riyadh, Saudi Arabia
National Guard Hospital
Riyadh, Saudi Arabia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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