Tolerance of Healthy Term Infants Fed Infant Formulas
1 other identifier
interventional
190
1 country
15
Brief Summary
The objective of the study is to assess comparative gastrointestinal tolerance of normal term infants to various milk-protein infant formulas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2008
Shorter than P25 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 24, 2008
CompletedFirst Posted
Study publicly available on registry
June 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedJanuary 5, 2009
January 1, 2009
4 months
June 24, 2008
January 2, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Gastrointestinal tolerance
0-8 days of age until 28 days of age
Secondary Outcomes (1)
GI and intake parameters
0-8 to 28 days of age
Study Arms (5)
1
EXPERIMENTALExperimental milk protein based infant formula with varying carbohydrate and protein source
2
EXPERIMENTALExperimental milk protein based infant formula with varying carbohydrate and protein source
3
EXPERIMENTALExperimental milk protein based infant formula with varying carbohydrate and protein source
4
EXPERIMENTALExperimental milk protein based infant formula with varying carbohydrate and protein source
5
EXPERIMENTALExperimental milk protein based infant formula with varying carbohydrate and protein source
Interventions
ad lib for 0-8 days of age until 28 days of age
Eligibility Criteria
You may qualify if:
- Healthy, term infants; singleton birth; 37-42 weeks of age; \>2490gms at birth; 0-8 days of age
You may not qualify if:
- medications/foods/formulas affecting GI tolerance;adverse medical history with possible effect on tolerance or growth
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (15)
Global Clinical Investigation
Aventura, Florida, 33180, United States
University of South Florida
Tampa, Florida, 33606, United States
University of Iowa
Coralville, Iowa, 52241, United States
Medical Associates Clinic
Dubuque, Iowa, 52002, United States
Kentucky Pediatric Research
Bardstown, Kentucky, 40004, United States
PediaResearch, Inc
Owensboro, Kentucky, 42301, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Midwest Children's Health Research Institute, LLC
Lincoln, Nebraska, 68504, United States
The Center for Human Nutrition
Omaha, Nebraska, 68105, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Pediatric Associates of Fairfield
Fairfield, Ohio, 45014, United States
Ohio Pediatric Research Association
Huber Heights, Ohio, 45424, United States
Institute of Clinical Research
Mayfield Heights, Ohio, 44124, United States
Primary Physicians Research, Inc
Pittsburgh, Pennsylvania, 15241, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Study Officials
- STUDY DIRECTOR
Steven Davis, PhD
Abbott Nutrition
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 24, 2008
First Posted
June 26, 2008
Study Start
June 1, 2008
Primary Completion
October 1, 2008
Study Completion
December 1, 2008
Last Updated
January 5, 2009
Record last verified: 2009-01