Open-label Study to Evaluate the Gastrointestinal Tolerance of a New Infant Formula in Healthy, Term, Asian Infants

Danone Asia Pacific Holdings Pte, Ltd.5 sites in 2 countries50 target enrollmentSeptember 2012

Overview

This study is initiated to investigate the gastrointestinal tolerance of a new infant formula in healthy, term, Asian infants.

Registry

clinicaltrials.gov

Start Date

September 2012

End Date

December 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Responsible Party

Sponsor

•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.

•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.