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OpenTrials
Completed

NCT Number: NCT01573884

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

Completed

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Key information

Conditions

Healthy Infant and Mother Pairs

Age range

Up to 17 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Northpoint Pediatrics, Indianapolis, Indiana, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Primary outcomes

  1. Viral load in cell cultures

    Time frame: 14 days

Secondary outcomes

  1. Changes in viral load and cytokine profiles

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Apr 10, 2012
Registry last updated
Apr 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.