Healthy term infants
Conditions
Interventions
Duration of intervention: 13-17 weeks.
Intervention group: Infant formula containing prebiotics and ferments.
Control group: Infant formula without prebiotics and ferments.
A reference group with f
Sponsors
Danone Research – Centre for Specialised Nutrition
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy and term infants (gestational age ≥ 37 and ≤ 42 weeks); 2. Infants who are exclusively formula fed (mothers who have chosen not to breastfeed or mothers who ceased breastfeeding by time of inclusion), or; 3. Infants who are exclusively breastfed (mothers who are willing to breastfed for at least till their infant is 17 weeks of age); 4. Birth weight between 2,5 - 4,5 kg; 5. Age ≤ 28 days (preferably as soon as possible after birth); 6. Written informed consent from parents or legal guardians.
Exclusion criteria
Exclusion criteria: 1. Infants fed with infant formula containing probiotics or synbiotics prior to study entry; 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(i.e. one of the biological parents diagnosed with asthma, hay fever, nasal allergy, eczema, skin allergy, and/or food allergy) ; 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/legal guardian to comply with the protocol requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence, occurrence and severity of gastrointestinal symptoms. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To explore the effect on quality of life and on digestion-related parameters; 2. To investigate adequate growth of the study product groups compared to WHO Child Growth Standards; 3. To describe the data of the breastfed reference group. | — |
Contacts
Public ContactL. Stet
Sr. Clinical Study Manager - Baby Nutrition Danone Research - Clinical Studies Platform P.O. Box 7005
Outcome results
None listed