Tolerance of Healthy Term Infants Fed Infant Formulas #4
NCT ID: NCT01155414
Last Updated: 2011-11-01
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
PHASE3
168 participants
INTERVENTIONAL
2010-03-31
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Investigational infant formula A
Investigational Protein Hydrolysate formula
Investigational Infant Formula A
Investigational infant formula ad lib
Hydrolysate based Infant Formula
Hydrolysate based infant formula
Infant formula ad lib
Investigational Infant Formula B
Investigational Protein Hydrolysate Formula
Investigational Infant Formula B
Investigational infant formula ad lib
Interventions
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Hydrolysate based infant formula
Infant formula ad lib
Investigational Infant Formula A
Investigational infant formula ad lib
Investigational Infant Formula B
Investigational infant formula ad lib
Eligibility Criteria
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Inclusion Criteria
* Birth weight was \> 2490 g.
* Between 0 and 8 days of age.
* Infants using medications (including OTC such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled unless both the parent and the physician agree to discontinue these agents prior to enrollment.
* Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study, unless instructed otherwise by their healthcare professional.
* Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study.
Exclusion Criteria
1 Day
8 Days
ALL
Yes
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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Marlene Borschel, PhD
Role: STUDY_CHAIR
Abbott Nutrition
Locations
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Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States
Alabama Clinical Therapeutics, LLC
Dothan, Alabama, United States
SCORE Physician Alliance
St. Petersburg, Florida, United States
University of Iowa
Coralville, Iowa, United States
Medical Associates Clinic, PC
Dubuque, Iowa, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Ohio Pediatric Research Association
Huber Heights, Ohio, United States
Institute of Clinical Research
Mayfield Heights, Ohio, United States
Pediatric Clinical Research Office
Hershey, Pennsylvania, United States
The Jackson Clinic, PA
Jackson, Tennessee, United States
Countries
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Other Identifiers
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AK75
Identifier Type: -
Identifier Source: org_study_id