Healthy Infants
Conditions
Keywords
Healthy, term, Asian infants, Infant formula
Brief summary
This study is initiated to investigate the gastrointestinal tolerance of a new infant formula in healthy, term, Asian infants.
Interventions
OTHERInfant Formula
Standard cow's milk based infant formula with added prebiotic oligosaccharides, and a modified fat blend and protein composition
Sponsors
Danone Asia Pacific Holdings Pte, Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Healthy, well-nourished, term, Asian infants (gestational age ≥ 37 1/7 and ≤ 41 6/7 weeks) * The mother had unequivocally decided not to exclusively breast-feed * Formula fed for at least one week, receiving at least two formula feedings per day * Birth weight appropriate for gestational age (AGA), 2500-4000g * Written informed consent from parent(s) and/or legal guardian, aged ≥ 18 years.
Exclusion criteria
* Age \> 17 weeks * Infants known to have current or previous illnesses/conditions or intervention which could interfere with the study (impacting tolerance and/or growth), such as gastrointestinal malformations, chronic diarrhoea, malabsorptive syndrome, malnutrition, congenital immunodeficiency, or major surgery, as per investigator's clinical judgement * Infants who suffered from gastroenteritis or diarrhoea in the last 4 weeks preceding study start. * Infants who used any medication or nutritional supplements (except for vitamin supplementation to complement breastfeeding) in the 4 weeks preceding study start. * Infants who have medical conditions for which a special diet other than standard (non hydrolysed) cow's milk-based infant formula is required (such as cow's milk allergy, soy protein allergy, fish protein allergy, egg protein allergy, lactose intolerance, galactosemia). * Infants with any history of or current participation in any other study involving investigational or marketed products. * Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal tolerance | up to Week 6 | Gastrointestinal tolerance is measured by stool consistency and gastrointestinal symptoms. |
Other
| Measure | Time frame |
|---|---|
| Anthropometry | Week 3, Week 6 |
| Use of medication and nutritional supplements | Week 1, Week 3, Week 6 and Week 8 |
| Number, type and severity of (serious) adverse events | Week 1, Week 3, Week 6 and Week 8 |
Countries
Indonesia, Thailand
Outcome results
None listed