Stool consistency Gastrointestinal (dis)comfort
Conditions
Interventions
Commercial available infant formula as a reference
Adapted infant formula I different processing
Adapted infant formula II different processing and different fat blend
Sponsors
FrieslandCampina
Eligibility
Inclusion criteria
Inclusion criteria: - Healthy and term infants (gestational age >= 37 and 500 mL formula/day) or exclusively formula fed - At least 30 infants per arm (n=90 in total) are exclusively formula fed (mothers who have chosen not to breastfeed or mothers who ceased breastfeeding for at least 1 week before inclusion) - Birth weight between 2.5 and 4.5 kg - Age < 40 days
Exclusion criteria
Exclusion criteria: - Congenital condition and/or previous or current illness that could interfere with study - Known or increased risk of cow's milk allergy and/ or lactose intolerance (i.e. one of the biological parents and or siblings diagnosed with cow's milk allergy, asthma, hay fever, etc.) - Having a mother suffering from diabetes during pregnancy - Participation in another clinical trial - Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements (including to fill in the diaries and to wait with introducing weaning foods until 4 months of age) - Use of antibiotics at the time of screening, or during the past two weeks - Being one of multiple birth (i.e. twins, triplets)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Stool consistency - Protein and fat digestion | — |
Secondary
| Measure | Time frame |
|---|---|
| - Stool frequency - Stool amount - Stool color - Gastrointestinal symptoms - Crying time - Fecal parameters | — |
Contacts
Public ContactI.M.S. Tan-Khouw
61 Quality Rd
Outcome results
None listed