Healthy Infant and Mother Pairs
Conditions
Brief summary
* Exploratory analyses of the immune response in a ex vivo culture system * Characterization of the composition of maternal milk and infant urine
Interventions
None listed
Sponsors
Abbott Nutrition
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Days
Healthy volunteers
Yes
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 -
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Viral load in cell cultures | 14 days |
Secondary
| Measure | Time frame |
|---|---|
| Changes in viral load and cytokine profiles | 14 days |
Countries
United States
Outcome results
None listed