The goal of this clinical trial is to study growth (weight gain per day) in healthy full-term infants who consume the investigational infant formula containing beneficial ingredients against infants consuming a control infant formula.
The key secondary outcome is to study sIgA levels from faecal samples at endline while controlling for baseline levels.
Parents of the enrolled infants will be asked to complete a diary, let their infant undergo physical examinations and complete questionnaire and feed their infant the assigned infant formula
Full-term infants (born between gestational age ≥ 37 weeks[Lv45.1] - 42 weeks).
Healthy birthweight (according to WHO Child Growth Standards): 2500 g ≤ birthweight ≤ 4200 g (corresponding to Z-scores between the range of -2 SD and +2 SD)
Boys and girls
Apparently healthy at birth and screening
Severe acquired or congenital diseases, mental or physical disorders, including cow's milk protein allergy, lactose intolerance and diagnosed medical conditions that are known to affect study outcomes (e.g. GI disorders, growth, immune-related diseases)
Incapability of parents to comply with the study protocol
Illiterate parents (i.e. not able to read and write in local language)
Participation in another clinical trial
Parallel
Infant Formula
Combination productthe experimental formula contains milk fat, MFGM, Lactoferrin, GOS and 2'FL
Infant Formula
Combination productStandard infant formula complying to (inter-)national legislation
Breastfeeding
Combination productExclusively breastfeeding
Growth
weight gain per day
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This trial is not recruiting at the moment. You can still explore other options:
