Tolerance of Healthy Term Infants Fed Infant Formulas #3
NCT ID: NCT00977964
Last Updated: 2010-11-25
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
270 participants
INTERVENTIONAL
2009-09-30
2010-01-31
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 Protein Formula Process A
Experimental milk protein infant formula Process A
ad lib for 1-8 days of age until 28 days of age
Milk Based Protein Formula Process B
Experimental milk protein infant formula Process B
ad lib from 1-8 days of age until 28 days of age
Milk Based Protein Formula Process C
Experimental milk protein infant formula Process C
ad lib from 1-8 days of age to 28 days of age
Milk Based Protein Formula Process D
Experimental milk protein infant formula Process D
ad lib from 1-8 days of age until 28 days of age
Milk Based Protein Formula Process E
Experimental milk protein infant formula Process E
ad lib from 1-8 days of age until 28 days of age
Milk Based Protein Formula Process F
Experimental milk protein infant formula Process F
ad lib from 1-8 days of age until 28 days of age
Interventions
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Experimental milk protein infant formula Process A
ad lib for 1-8 days of age until 28 days of age
Experimental milk protein infant formula Process B
ad lib from 1-8 days of age until 28 days of age
Experimental milk protein infant formula Process C
ad lib from 1-8 days of age to 28 days of age
Experimental milk protein infant formula Process D
ad lib from 1-8 days of age until 28 days of age
Experimental milk protein infant formula Process E
ad lib from 1-8 days of age until 28 days of age
Experimental milk protein infant formula Process F
ad lib from 1-8 days of age until 28 days of age
Eligibility Criteria
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Inclusion Criteria
* Infant is a singleton from a full term birth.
* Infant's birth weight was \> 2490 g (\~5 lbs 8 oz.
* Infant is between 0 and 8 days of age at enrollment.
* Infants using medications, home remedies ,herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled.
* 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, unless instructed otherwise by their healthcare professional.
Exclusion Criteria
* Infant has been treated with antibiotics.
* Infant has received probiotics.
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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Caude T Ashley, MD
Role: PRINCIPAL_INVESTIGATOR
Alabama Clinical Therapeutics, LLC
Terri L Ashmeade, MD
Role: PRINCIPAL_INVESTIGATOR
USF Department of Pediatrics
Jay Cohen, MD
Role: PRINCIPAL_INVESTIGATOR
Discovery Clinical Research, Inc.
Timothy Crum, MD
Role: PRINCIPAL_INVESTIGATOR
Rockwood Clinic
Cole Ezeoke, MD
Role: PRINCIPAL_INVESTIGATOR
North Georgia Clinical Research, White's Pediatrics
Sharon Groh-Wargo, PhD, RD, LD
Role: PRINCIPAL_INVESTIGATOR
MetroHealth Medical Center
James Guerrieri, MD
Role: PRINCIPAL_INVESTIGATOR
Institute of Clinical Research, LLC
James Hedrick, MD
Role: PRINCIPAL_INVESTIGATOR
Kentucky Pediatric Research
Jeffrey Hirschfield, MD
Role: PRINCIPAL_INVESTIGATOR
SCORE Physician Alliance, LLC
Kevin Mullen, MD
Role: PRINCIPAL_INVESTIGATOR
Medical Associates Clinic, PC
Chris Peltier, MD
Role: PRINCIPAL_INVESTIGATOR
Pediatric Associates of Mount Carmel, Inc.
Martin J Schear, MD
Role: PRINCIPAL_INVESTIGATOR
Dayton Clinical Research
Julie Shepard, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio Pediatric Research Association
William Stepp, MD
Role: PRINCIPAL_INVESTIGATOR
Sarah Cannon Research Institute, LLC
L Louise Tetrick, MD
Role: PRINCIPAL_INVESTIGATOR
Northpoint Pediatrics
Locations
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Alabama Clinical Therapeutics
Dothan, Alabama, United States
All Women's Heatlthcare of West Broward, Inc: Discovery Clinical Research, Inc
Plantation, Florida, United States
SCORE Physician Alliance, LLC
St. Petersburg, Florida, United States
University of South Florida
Tampa, Florida, United States
North Georgia Clinical Research
Dalton, Georgia, United States
Northpoint Pediatrics, LLC
Indianapolis, Indiana, United States
Medical Associates Clinic, PC
Dubuque, Iowa, United States
Kentucky Pediatric / Adult Research
Bardstown, Kentucky, United States
Pediatric Associates of Mount Carmel, Inc
Cincinnati, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Dayton Clinical Research
Dayton, Ohio, United States
Ohio Pediatric Research Association, Inc.
Huber Heights, Ohio, United States
Institute of Clinical Research
Mayfield Heights, Ohio, United States
The Jackson Clinic, PA
Jackson, Tennessee, United States
Rockwood Clinic North - Pediatrics
Spokane, Washington, United States
Countries
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References
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Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2.
Other Identifiers
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AK70
Identifier Type: -
Identifier Source: org_study_id