Healthy
Conditions
Keywords
healthy babbies, infant formula, growth, HMO
Brief summary
The primary objective of this clinical study is to show that infants fed a standard starter infant formula with 2 Human Milk Oligosaccharides (HMOs) have a growth in line with infants fed a standard starter infant formula without HMOs.
Interventions
OTHERInfant Formula
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
No minimum to 14 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy babies * Full term babies (37 weeks ≤ gestation ≤ 42 weeks) * birth weight between 2500 g- 4500g * Having obtained the baby's legal representative's informed consent. * FF groups: babies aged between birth and 14 days, exclusively formula-fed at time of enrollment, whose mother independently elected, before enrollment, not to breastfeed • BF group: babies aged 3 months (+/- 5 days), exclusively breastfed since birth.
Exclusion criteria
* Congenital illness or malformation that may affect growth * Significant pre-natal and/or serious post-natal disease before enrollment (by medical decision) * Minor parent(s) * Newborn whose parents / caregivers cannot be expected to comply with study procedures * Currently participating or having participated in another clinical trial since birth, except for BF group, where vaccines studies are allowed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Growth | 4 months of life | child growth (body weight) from enrollment to 4 months of age |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Digestive tolerance (stool charecteristics, bowel movements,behavior patterns) | every month during 6 months | Parents are asked to complete a diary on digistive tolerance of their child |
| Product compliance (quantity of formula in ml consumed on the 3 days before visit) | every month for 6 months | Parents are asked to complete a diary on the product compliance |
| Growth | 6 and 12 months of age | — |
| Stool microbiota | 3 and 12 months of age | — |
| Gene expression | 3 and 12 months of age | — |
| Morbidity | ongoing for 1 year | — |
Countries
Belgium, Italy
Outcome results
None listed