Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
180 participants
INTERVENTIONAL
2007-09-30
2008-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Milk based formula A
Experimental milk based infant formula
Milk based formula A
feed as per HCP directions
Standard formula
standard milk based infant formula
#2 Standard formula
Feed as per HCP directions
Reference
Human milk
#3 Human Milk
Feed as per HCP directions
Milk based formula C
Experimental milk based infant formula
Milk based formula C
Feed as per HCP direction
Interventions
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Milk based formula A
feed as per HCP directions
#2 Standard formula
Feed as per HCP directions
#3 Human Milk
Feed as per HCP directions
Milk based formula C
Feed as per HCP direction
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Infant has been treated with antibiotics.
8 Days
ALL
Yes
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Abbott Nutrition
Principal Investigators
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Timberly A. Williams, M.S.
Role: STUDY_CHAIR
Abbott Nutrition, Abbott Laboratories
Locations
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The Pediatric Clinic
North Little Rock, Arkansas, United States
USF
Tampa, Florida, United States
North Georgia Clinical Research, White's Pediatrics
Dalton, Georgia, United States
Medical Associates Clinic
Dubuque, Iowa, United States
Midwest Children's Health Research Institute, LLC
Lincoln, Nebraska, United States
The Childrens Medical Group LLC
Poughkeepsie, New York, United States
Levine Childrens Hospital
Charlotte, North Carolina, United States
Ohio Pediatrics, Inc.
Huber Heights, Ohio, United States
Institute of Clinical Research
Mayfield Heights, Ohio, United States
Scott & White Memorial Hospital
Temple, Texas, United States
Countries
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References
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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.
Other Identifiers
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AK53
Identifier Type: -
Identifier Source: org_study_id