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Tolerance of Healthy, Term Infants to Infant Formulas

This study has been completed.
Sponsor:
Information provided by:
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT00543673
First received: October 5, 2007
Last updated: July 3, 2008
Last verified: June 2008
History of Changes

October 5, 2007
July 3, 2008
September 2007
May 2008   (final data collection date for primary outcome measure)
Mean rank stool consistency (MRSC) [ Time Frame: Study Day 1 to Visit 3 ] [ Designated as safety issue: No ]
Mean rank stool consistency (MRSC) [ Time Frame: Study Day 1 to Visit 3 ]
Complete list of historical versions of study NCT00543673 on ClinicalTrials.gov Archive Site
MRSC, percent watery stools, average number of stools per day, percent of feedings with spit-up and/or vomiting [ Time Frame: 4 months ] [ Designated as safety issue: No ]
MRSC, percent watery stools, average number of stools per day, percent of feedings with spit-up and/or vomiting [ Time Frame: 4 months ]
Not Provided
Not Provided
 
Tolerance of Healthy, Term Infants to Infant Formulas
Tolerance of Healthy, Term Infants to Infant Formulas

To assess the gastrointestinal tolerance of healthy full-term infants fed either experimental formula or a control formula
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy
  • Other: Milk based formula A
    feed as per HCP directions
    Other Name: AN0710A
  • Other: #2 Standard formula
    Feed as per HCP directions
    Other Name: AN0710B
  • Other: #3 Human Milk
    Feed as per HCP directions
    Other Name: Human Milk
  • Other: Milk based formula C
    Feed as per HCP direction
    Other Name: AN0710C
  • Experimental: Milk based formula A
    Experimental milk based infant formula
    Intervention: Other: Milk based formula A
  • Active Comparator: Standard formula
    standard milk based infant formula
    Intervention: Other: #2 Standard formula
  • Reference
    Human milk
    Intervention: Other: #3 Human Milk
  • Experimental: Milk based formula C
    Experimental milk based infant formula
    Intervention: Other: Milk based formula C
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
June 2008
May 2008   (final data collection date for primary outcome measure)

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.
Both
up to 8 Days
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00543673
AK53
No
Bobbie Swearengin, Director Clinical Research Operations, Abbott Nutrition
Abbott Nutrition
Not Provided
Study Chair: Timberly A. Williams, M.S. Abbott Nutrition, Abbott Laboratories
Abbott Nutrition
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP