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Tolerance of Healthy, Term Infants to Infant Formulas

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00543673
First Posted: October 15, 2007
Last Update Posted: July 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott Nutrition
October 5, 2007
October 15, 2007
July 4, 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 ]
Same as current
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 ]
Same as current
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Williams T, Choe Y, Price P, Katz G, Suarez F, Paule C, Mackey A. Tolerance of formulas containing prebiotics in healthy, term infants. J Pediatr Gastroenterol Nutr. 2014 Nov;59(5):653-8. doi: 10.1097/MPG.0000000000000513.

*   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.
Sexes Eligible for Study: All
up to 8 Days   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00543673
AK53
No
Not Provided
Not Provided
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