Assessing Early Behavioral Indicators of Formula Tolerance

Completed · Not applicable

Conditions studied: Tolerance

In brief

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

Key facts

Study ID

NCT02340143

Run by

Mead Johnson Nutrition

People needed

71

Starts

2015-01-01

Expected to finish

2016-08-01

Last updated by the study team

2016-09-14

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Nutrition Research Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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