Efficacy and Safety of an Infant Formula With Milkfat and Prebiotics

Forest Hospital Protestant Hospital

Status

Completed

Conditions

Food Intolerance

Stool Flora

Infections

Constipation

Stool Biochemistry

Treatments

Dietary Supplement: new infant formula with prebiotics and beta-palmitate

Study type

Interventional

Funder types

Other

Identifiers

NCT01603719

EWK-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

128 patients

Sex

All

Ages

Under 10 days old

Volunteers

Accepts Healthy Volunteers

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