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Clinical Trials/NCT01573884
NCT01573884CompletedNot Applicable

Ex Vivo Exploratory Analysis in Healthy Full-term Infants

Abbott Nutrition2 sites in 1 country54 target enrollmentStarted: September 2011Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
54
Locations
2
Primary Endpoint
Viral load in cell cultures
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
— to 17 Days (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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 -

Outcomes

Primary Outcomes

Viral load in cell cultures

Time Frame: 14 days

Secondary Outcomes

  • Changes in viral load and cytokine profiles(14 days)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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