Healthy term infants.
Conditions
Interventions
Duration of intervention: 15-19 weeks
1. Intervention groups: Cow's milk-based fermented infant formulae with prebiotics (combination of two pre-existing products which stimulate digestion)
2. Control groups: Cow's milk-based fermented/non-fermented infant formulae with/without prebiotics.
Sponsors
Danone Research - Centre for Specialised Nutrition
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy, term (gestational age ¡Ý 37 and ¡Ü 42 weeks) infants; 2. Birth weight between 2,5-4,5 kg. These data is derived from WHO growth curves to look at group between 10th and 90th percentile; 3. Age ¡Ü 28 days; 4. Parents' or guardian's aged >18 years, written informed consent.
Exclusion criteria
Exclusion criteria: 1. Breastfeeding; 2. Congenital condition and/or previous or current illness that could interfere with study; 3. Known or increased risk of cow¡¯s milk allergy, soy allergy and/or lactose intolerance; 4. Having a mother suffering from diabetes during pregnancy; 5. Participation in another clinical trial; 6. Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight gain in grams per day from study entry until 17 weeks of age. | — |
Secondary
| Measure | Time frame |
|---|---|
| Anthropometrics other than weight gain, gastrointestinal tolerance, crying, sleeping, stool characteristics, faecal parameters, safety, use of medication and nutritional supplements. | — |
Contacts
Public ContactManon Gadellaa
PO Box 7005
Outcome results
None listed