Ex Vivo Exploratory Analysis in Healthy Full-term Infants

Completed

Conditions studied: Healthy Infant and Mother Pairs

In brief

* Exploratory analyses of the immune response in a ex vivo culture system * Characterization of the composition of maternal milk and infant urine

Key facts

Study ID

NCT01573884

Run by

Abbott Nutrition

People needed

54

Starts

2011-09-01

Expected to finish

2012-02-01

Last updated by the study team

2012-04-10

Who can join

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

You may qualify if…

• Infant or infant-mother pair in good health
• Infant or infant-mother pair is from smoke-free home
• Infant is a singleton, full term
• birth weight was > 2490 g
• Between 0 and 17 days of age at enrollment
• Human milk fed infants must have been exclusively human milk-fed since birth; formula fed infants must have received Similac Advance or Similac Sensitive since birth
• Parents confirm their intention not to administer vitamin or mineral supplements (excluding vitamin or mineral supplements containing vitamin D), solid foods or juices to their infant from enrollment throughout the study

You may not qualify if…

• An adverse maternal, fetal or infant medical history, including gestational diabetes that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
• Infant has been treated with antibiotics
• Participation in another study -

Where it is running

• Northpoint Pediatrics — Indianapolis, Indiana, United States
• Institute of Clinical Research — Mayfield Heights, Ohio, United States

Full record on ClinicalTrials.gov

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