Nutritive Effects of Prebiotics on Early Postnatal Behavioral Measures of Tolerance

Mead Johnson Nutrition

Status: Completed

Conditions: Behavioral Measures of Tolerance

Treatments: Other: Previously marketed cow's mlik-based infant formula; Other: Marketed cow's milk-based infant formula with prebiotics

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02118935

6023

Details and patient eligibility

About

The study is intended to measure infant comfort, behavior, and sleep when consuming study formula with prebiotics compared to infants who consume a study formula without the prebiotics.

Enrollment: 161 patients

Sex: All

Ages: 14 to 35 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Singleton, 14-35 days of age at baseline
• Term infant with birth weight of a minimum of 2500 grams
• Solely formula-fed
• Signed Informed Consent and Protected Health Information authorization

Exclusion criteria

• History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
• Feeding difficulties or formula intolerance
• Maternal history of illicit drug use or psychiatric disease

Trial design

161 participants in 2 patient groups

Previously marketed cow's milk-based infant formula

Active Comparator group

Treatment:

Other: Previously marketed cow's mlik-based infant formula

Marketed cow's milk-based infant formula with prebiotics

Experimental group

Treatment:

Other: Marketed cow's milk-based infant formula with prebiotics