Actively Recruiting
Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants
Led by Société des Produits Nestlé (SPN) · Updated on 2025-12-19
234
Participants Needed
3
Research Sites
250 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will assess the effect of partially hydrolyzed, whey-based infant formulas on growth and gastrointestinal tolerance in healthy term infants.
CONDITIONS
Official Title
Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained from parent or legal representative
- Infant born at 37 or more completed weeks gestation
- Infant birth weight between 2.5 kg and 4.5 kg
- Singleton birth
- Infant is 28 days old or younger
- Mother has decided to fully formula-feed and infant is no longer breastfeeding or receiving breast milk
- Parent or legal representative is of legal adult age, understands study documents, and can comply with study requirements
You will not qualify if you...
- Chronic infectious, metabolic, genetic illness or other disease affecting feeding or growth
- Major congenital or chromosomal abnormalities affecting growth (e.g., congenital heart disease, cystic fibrosis)
- Maternal medical conditions affecting infant growth (e.g., untreated preeclampsia, gestational diabetes)
- Infants requiring special dietary needs other than standard formula
- Known or suspected cow's milk protein intolerance or allergy, lactose intolerance, or severe food allergies affecting diet
- Other medical or psychiatric conditions making participation unsuitable as judged by the investigator
- Current or previous participation in another interventional clinical trial before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
National Guard Hospital
Jeddah, Saudi Arabia
Actively Recruiting
2
King Faisal Specialist Hospital and Research Center
Riyadh, Saudi Arabia
Completed
3
National Guard Hospital
Riyadh, Saudi Arabia
Active, Not Recruiting
Research Team
A
Anthony de Cozar
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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