Efficacy and Safety of an Infant Formula With Milkfat and Prebiotics

Safety and Efficacy of an Infant Starter Formula With Prebiotics (GOS) and a Higher Content of Beta-palmitate on Stool Characteristics, Food Tolerance, Calcium Uptake, and Incidence of Infectious Disease in the First Year of Life

The purpose of this clinical trial is to evaluate the effect of a new infant starter formula with added prebiotics (GOS) and with a fat blend rich in beta-palmitate.

An experimental infant formula with added prebiotics (GOS) and with a higher content of palmitic acid esterified in beta-position is to be tested in a double-blinded randomized controlled trial.

The addition of prebiotics to an infant formula should favor growth of a beneficial bifidogenic intestinal flora and have positive effects on immunity, promote softer stool formation and short chain fatty acid content in the stools. Higher proportion of beta-palmitic acid esterified in 2nd position of the triglyceride should reduce formation of fatty acid-calcium soaps in the stools and promote calcium and fat absorption in the gut, therfor reduce symptoms of constipation and colics.

Inclusion Criteria:

• healthy term neonates
• gestational age 37 to 42 weeks
• birth weight 10th to 90th percentile (Voigt reference)
• infants being exclusively formula-fed at enrollment

Exclusion Criteria:

• infants with high risk of atopic disease due to family history
• congenital disorder or syndrome with need for special diet / impairment of growth
• antibiotic medication prior to enrollment