Gastrointestinal Tolerance Study of a New Infant Formula (BOOGIE)

Danone

Status: Completed

Conditions: Healthy Infants

Treatments: Other: Infant Formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT01681355

BLU.1.C/A

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: Under 17 weeks old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Intervention group

Experimental group

Description:

Healthy infants receiving standard cow's milk-based infant formula with added prebiotic oligosaccharides, and a modified fat blend and protein composition.

Treatment:

Other: Infant Formula