Efficacy of a New Infant Formula Composition on Gut Health in Infants
ConditionHealthy Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-3
SponsorFrieslandCampina
About this trial
The aim of this study is to investigate potential health benefits of the experimental formula. The main objective is whether the experimental formula elevates the relative abundance of Bifidobacterium in stool samples after 10 weeks, as compared a standard formula, aka control formula. In addition other markers of gut health, such as stool characteristics, and gut health symptoms will be monitored
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy, full term, infants with a birth weight between 2500-4500 grams
Parents independently from study decided to not breastfeed their infant
Parents agree to feed the assigned study formula as the infant's sole source of nutrition for the duration of the study
have read and voluntarily signed an informed consent form
Disqualifiers
suffering from any anatomic and/or physiologic condition that would interfere with normal growth, development or feeding
are required to take medications or supplements known to influence growth and development
have a maternal history with known adverse effects on the fetus and/or the newborn infant
have previous or current antibiotics use (antibiotics administered during delivery are permitted)
Trial design
Design model
Parallel
Treatments tested in this trial
Infant Formula
Other interventionad-libitum consumption of infant formula
Infant Formula with bioactive ingredients
Other interventionad-libitum consumption
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Experimental infant formulaExperimental treatment 1 intervention
Group B: Control formulaPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Bifidobacterium
Relative abundance of bifidobacterium from stool samples
Time frame
From enrollment to the end of treatment at 10 weeksSponsors and contacts
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Source ClinicalTrials.gov