Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants
Recruiting now · Not applicable
Conditions studied: Infant Nutritional Physiological Phenomena, Infant Formula, Infant Health, Infant Development, Growth and Development
In brief
This study will assess the effect of partially hydrolyzed, whey-based infant formulas on growth and gastrointestinal tolerance in healthy term infants.
Key facts
- Study ID
- NCT05868408
- Run by
- Société des Produits Nestlé (SPN)
- People needed
- 234
- Starts
- 2023-08-17
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-07-15
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
- 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).
- 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
You may not qualify if…
- 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
Where it is running
- Biomedical Research Institute — Cavite City, Philippines (enrolling)
- Biomedical Research Institute — Las Piñas, Philippines (enrolling)
- National Guard Hospital — Jeddah, Saudi Arabia
- King Faisal Specialist Hospital and Research Center — Riyadh, Saudi Arabia
- National Guard Hospital — Riyadh, Saudi Arabia
Full record on ClinicalTrials.gov
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