Assessing Early Behavioral Indicators of Formula Tolerance

Mead Johnson Nutrition

Status: Completed

Conditions: Tolerance

Treatments: Other: Control; Other: Investigational

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02340143

6025

Details and patient eligibility

About

The study is intended to assess the amount of crying and fussiness in infants fed an infant formula containing probiotics.

Enrollment: 71 patients

Sex: All

Ages: 14 to 28 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Singleton at birth
• Term infant with birth weight of 2500 g or more
• Crying or fussing for 3 or more hours per day
• Consuming mostly infant formula
• Signed Informed Consent and Protected Health Information authorization

Exclusion criteria

• Current use of extensively hydrolyzed or amino acid infant formula
• Planned use of probiotics during the study
• History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
• Enrollment in another interventional clinical research study

Trial design

71 participants in 2 patient groups

Control

Active Comparator group

Description:

Marketed partially hydrolyzed cow's milk protein infant formula

Treatment:

Other: Control

Investigational

Experimental group

Description:

Partially hydrolyzed cow's milk infant formula with a probiotic

Treatment:

Other: Investigational