Acceptance Of A Partially-Hydrolyzed Infant Formula

Acceptance Of A Partially-Hydrolyzed Infant Formula

This clinical trial will evaluate stool consistency in infants receiving one of two study formulas through a 14-day feeding period.

Inclusion Criteria:

• Singleton 28-300 days of age at randomization
• Gestational age less than or equal to 35 weeks
• Receiving minimum 18oz infant formula in the 24hrs prior to randomization
• History of hard stools or stooling difficulty
• Signed informed consent and protected health information

Exclusion Criteria:

• Current diagnosis of cow's milk protein allergy or intolerance
• Use of extensively hydrolyzed or amino acid formula at randomization
• Any abdominal or gastrointestinal surgery prior to randomization
• History of underlying metabolic or chronic disease or congenital malformation
• Organic causes of constipation