Ex Vivo Exploratory Analysis in Healthy Full-term Infants

Abbott

Status: Completed

Conditions: Healthy Infant and Mother Pairs

Study type: Observational

Funder types: Industry

Identifiers

NCT01573884

AK97

Details and patient eligibility

About

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

Enrollment: 54 patients

Sex: All

Ages: Under 17 days old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• 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

Exclusion Criteria:

• 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 -