Ex Vivo Exploratory Analysis in Healthy Full-term Infants

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

Study Overview

• Status: Completed
• Conditions: Healthy Infant and Mother Pairs

• Study Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Northpoint Pediatrics
  • Ohio
    • Mayfield Heights, Ohio, United States, 44124
      • Institute of Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 weeks (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

infant and mother pairs

Description

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 -

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Viral load in cell cultures	14 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in viral load and cytokine profiles	14 days

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Karen Goehring, MS, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: April 6, 2012
• First Submitted That Met QC Criteria: April 6, 2012
• First Posted (Estimate): April 10, 2012

Study Record Updates

• Last Update Posted (Estimate): April 10, 2012
• Last Update Submitted That Met QC Criteria: April 6, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: AK97