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Clinical Trials/NCT00543673
NCT00543673
Completed
Phase 2

Tolerance of Healthy, Term Infants to Infant Formulas

Abbott Nutrition10 sites in 1 country180 target enrollmentSeptember 2007
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ConditionsHealthy

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Healthy
Sponsor
Abbott Nutrition
Enrollment
180
Locations
10
Primary Endpoint
Mean rank stool consistency (MRSC)
Status
Completed
Last Updated
17 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

To assess the gastrointestinal tolerance of healthy full-term infants fed either experimental formula or a control formula

Registry
clinicaltrials.gov
Start Date
September 2007
End Date
June 2008
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •judged to be in good health.
  • •singleton from a full term birth with a gestational age of 37-42 weeks
  • •birth weight was \> 2490 g (\~5 lbs 8 oz)
  • •between 0 and 8 days of age at enrollment.
  • •Infant's parent(s) or a LAR has voluntarily signed and dated an ICF, approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.

Exclusion Criteria

  • •An adverse maternal, fetal or infant medical history thought by the investigator to have potential for effects on tolerance, growth, and/or development, including, but not limited to suspected maternal substance abuse.
  • •Infant has been treated with antibiotics.

Outcomes

Primary Outcomes

Mean rank stool consistency (MRSC)

Time Frame: Study Day 1 to Visit 3

Secondary Outcomes

  • MRSC, percent watery stools, average number of stools per day, percent of feedings with spit-up and/or vomiting(4 months)

Study Sites (10)

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