Actively Recruiting
Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants: a Double-blind, Randomized, Controlled, Multi-arm Trial
Led by Société des Produits Nestlé (SPN) · Updated on 2025-12-19
234
Participants Needed
3
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of partially hydrolyzed, whey-based infant formulas on growth and digestive tolerance in healthy full-term infants. This study compares different infant formulas to understand their impact on infant growth and gastrointestinal comfort during early life. The trial is randomized and controlled, involving multiple groups to assess the outcomes clearly and reliably. The study includes three groups: a control group receiving formula with intact protein at a minimum of 1.8 grams per 100 kilocalories, and two experimental groups that receive formulas with hydrolyzed protein at a minimum of 1.9 grams per 100 kilocalories. The second experimental formula differs by using a different partially hydrolyzed milk protein base. Participants receive these formulas during the first months of life, and the study is double-blinded to ensure impartial results. Participants will be followed from enrollment until six months of age, with primary growth outcomes measured through the first four months. Researchers will assess gastrointestinal tolerance, stooling patterns, atopic dermatitis severity, allergy symptoms, dietary intake, and various growth parameters including weight, length, and head circumference at multiple time points. The study includes thorough monitoring to understand formula effects on infant health and development.
CONDITIONS
Brief 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 at least one parent or legally acceptable representative
- Infant born at or after 37 completed weeks of gestation
- Infant birth weight between 2.5 kg and 4.5 kg
- Singleton birth (not twins or multiples)
- Infant age 28 days or younger
- Mother has decided to fully formula-feed and infant is no longer breastfed
- Parent or representative is of legal age, understands study information, and can follow study requirements
You will not qualify if you...
- Chronic infectious, metabolic, genetic illness or other diseases 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 needing special dietary requirements beyond standard formula
- Known or suspected cow's milk protein intolerance/allergy, lactose intolerance, or severe food allergies
- Other medical or psychiatric conditions making participation inappropriate
- Current or prior participation in another interventional clinical trial before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From enrollment to age 4 months
Participants receive one of three infant formulas to assess growth and tolerability during the first 4 months of life.
Visits at enrollment and ages 1, 2, 3, and 4 months
Duration - From age 4 months to 12 months
Participants are monitored for gastrointestinal tolerance, atopic dermatitis severity, allergy-related symptoms, and dietary intake up to 12 months of age.
Visits at ages 4, 6, and 12 months
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
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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