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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-28
SponsorSociété des Produits Nestlé (SPN)

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Control Formula
  • Experimental Formula 1
  • Experimental Formula 2

Treatment groups

234 Participants
are divided into 3 treatment groups