Ex Vivo Exploratory Analysis in Healthy Full-term Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-02-29

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Infant and Mother Pairs

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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 -

Maximum Eligible Age

17 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes