Healthy Term Infants Fed Milk-Based Formulas

Completed · Phase 3

Conditions studied: Healthy Term Infant

In brief

The objective is to assess the comparative fat and calcium absorption, and gastrointestinal (GI) tolerance in healthy normal term infants fed powdered milk-based formulas containing different fat blends.

Key facts

Study ID

NCT01617889

Run by

Abbott Nutrition

People needed

17

Starts

2011-03-01

Expected to finish

2012-08-01

Last updated by the study team

2013-02-15

Who can join

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

You may qualify if…

• Infant is judged to be in good health.
• Infant is singleton from a full term birth
• Infant's birth weight was > 2490 g.
• Infant is between 53 and 115 days of age
• Infant is on infant formula and tolerating infant formula feedings
• Parent(s) confirm they will not administer vitamin or mineral supplements, solid foods or juices for the duration of the study, unless instructed otherwise by their healthcare professional.
• Parent(s) and physician agree to discontinue the use of medications or home remedies, herbal preparations that might affect GI tolerance

You may not qualify if…

• Infant has received human milk within 7 days prior to SDay 1.
• Any adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development and includes maternal substance abuse
• Infant has been treated with antibiotics within 5 days prior to SDay 1
• Infant has received probiotics within 5 days prior to SDay 1.

Where it is running

• University of Colorado Denver — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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