To evaluate the growth of healthy term infants fed an experimental infant formula with a prebiotic, a commercial control infant formula with a probiotic, but without a prebiotic and human breast milk
Multisite, double-blind, randomized, controlled clinical trial. The purpose of the study is to determine if infants fed a standard infant formula with a prebiotic have a weight gain in line with infants fed a standard starter infant formula without a prebiotic.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
349
Formula-fed infants will be randomly assigned to receive one of the study formulas (CF or EF) orally, ad libitum, each day from Study Day 1 until Study Day 180, for a treatment duration of approximately 180 days.
Formula-fed infants will be randomly assigned to receive one of the study formulas (CF or EF) orally, ad libitum, each day from Study Day 1 until Study Day 180, for a treatment duration of approximately 180 days.
Algemeen Stedelijk Ziekenhuis Aalst
Aalst, Belgium
UZ Brussel
Brussels, Belgium
Kinderartsen Huis5
Hasselt, Belgium
Clinique Ste Elisabeth
Namur, Belgium
Growth
Growth (weight gain velocity)
Time frame: 120 days
Growth
Other growth outcomes will be compared to the World Health Organization 2006 Growth Standards and by treatment group
Time frame: Every month up to 6 months of age
Stool patterns (3-day GI symptom and behavior diary - stool frequency and stool consistency)
Stool patterns (3-day GI symptom and behavior diary - stool frequency and stool consistency)
Time frame: Every month up to 6 months of age
GI tolerance (3-day GI symptom and behavior diary - including GI symptoms, GI-related behaviors, and milk intake)
GI tolerance (3-day GI symptom and behavior diary - including GI symptoms (frequency and amount of spitting-up/vomiting, and frequency of flatulence), GI-related behaviors (duration of crying and fussiness, sleeping, and the frequency of excessive crying episodes), and milk intake)
Time frame: Every month up to 6 months of age
Fecal microbiota composition and diversity (16S rRNA sequencing and qPCR)
Fecal microbiota composition, diversity, and abundance
Time frame: Every month up to 4 months of age
Fecal markers (pH, fecal organic acids, and protein markers of gut health)
Fecal markers (pH, fecal organic acids, and protein markers of gut health)
Time frame: Every month up to 4 months of age
Gene expression (infant exfoliated and microbial cell gene expression by shotgun sequencing)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CHwapi
Tournai, Belgium
Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda, Ospedale Maggiore Policlinico
Milan, Italy
AOUP "Paolo Giaccone"
Palermo, Italy
Gene expression (infant exfoliated and microbial cell gene expression by shotgun sequencing)
Time frame: Up to 3 months of age
Adverse events / Morbidity
Adverse events / Morbidity
Time frame: 180 days