Ex Vivo Exploratory Analysis in Healthy Full-term Infants

Completed

• Conditions: Healthy Infant and Mother Pairs

• Registration Number: NCT01573884
• Lead Sponsor: Abbott Nutrition

Brief Summary

* Exploratory analyses of the immune response in a ex vivo culture system

* Characterization of the composition of maternal milk and infant urine

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2011-12
• Study Completion: 2012-02
• Status Verified: 2012-04
• Study First Submitted: 2012-04-06
• Study First Submitted QC: 2012-04-06
• Last Update Submitted: 2012-04-06
• Study First Posted: 2012-04-10
• Last Update Posted: 2012-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Viral load in cell cultures	14 days

Secondary Outcome Measures

Name	Time	Method
Changes in viral load and cytokine profiles	14 days

Trial Locations

Locations (2)

Institute of Clinical Research; 🇺🇸 Mayfield Heights, Ohio, United States

Northpoint Pediatrics; 🇺🇸 Indianapolis, Indiana, United States