Healthy Infants
Conditions
Keywords
infant, formula, microbiota, gut health, RCT
Brief summary
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
Interventions
OTHERInfant Formula
ad-libitum consumption of infant formula
OTHERInfant Formula with bioactive ingredients
ad-libitum consumption
Sponsors
FrieslandCampina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
0 Days to 3 Days
Healthy volunteers
Yes
Inclusion criteria
* 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 * parents are capable of completing study procedures required by the protocol
Exclusion criteria
* 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) * have received or are planning to receive probiotics, prebiotics, or nutritional supplements prior to and throughout the trial (excluding vitamin D and vitamin K supplementation) * personal history of or parents/siblings diagnosed with cow's milk protein allergy or lactose intolerance * multiple birth * participation in another trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bifidobacterium | From enrollment to the end of treatment at 10 weeks | Relative abundance of bifidobacterium from stool samples |
Countries
Bulgaria
Outcome results
None listed