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
NA
280 participants
INTERVENTIONAL
2007-08-31
2008-09-30
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
QUADRUPLE
Study Groups
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1
cow-milk based infant formula
fecal bacteria analysis
ad lib feeding
2
cow milk based infant formula with prebiotics
fecal bacteria analysis
ad lib feeding
3
human milk reference group
fecal bacteria analysis
ad lib feeding
Interventions
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fecal bacteria analysis
ad lib feeding
Eligibility Criteria
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Inclusion Criteria
* 21-30 days of age
Exclusion Criteria
* Use of antibiotics or steroids
21 Days
30 Days
ALL
Yes
Sponsors
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Mead Johnson Nutrition
INDUSTRY
Responsible Party
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Mead Johnson
Principal Investigators
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Deolinda Scalabrin, MD
Role: STUDY_DIRECTOR
Mead Johnson Nutrition
Locations
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Central Arkansas Pediatric Clinic
Benton, Arkansas, United States
Arkansas Pediatrics of Conway
Conway, Arkansas, United States
The Children's Clinic of Jonesboro
Jonesboro, Arkansas, United States
Altamonte Pediatric Associates
Altamonte Springs, Florida, United States
Advocate Center for Pediatric Research
Park Ridge, Illinois, United States
Internal Medicine and Pediatrics
Fishers, Indiana, United States
East Washington Pediatrics
Indianapolis, Indiana, United States
Children's Hospital of Iowa
Coralville, Iowa, United States
University of Kansas Medical University
Kansas City, Kansas, United States
PTCU/Children and Youth Project
Louisville, Kentucky, United States
ACC Pediatric Research
Bossier City, Louisiana, United States
ProMed Healthcare
Kalamazoo, Michigan, United States
ProMed Pediatrics
Portage, Michigan, United States
ProMed Physicians-Pediatrics
Richland, Michigan, United States
The Center for Human Nutrition
Omaha, Nebraska, United States
Winthrop Pediatric Associates
Mineola, New York, United States
Cary Pediatric Center, P.A.
Cary, North Carolina, United States
Pediatric Associates of Mt. Carmel, Inc.
Cincinnati, Ohio, United States
Pediatric Associates of Fairfield, Inc.
Fairfield, Ohio, United States
Northeast Cincinnati Pediatric Assoc
Mason, Ohio, United States
Red Lion Pediatrics
Philadelphia, Pennsylvania, United States
Alpha Clinical Research
Clarksville, Tennessee, United States
Austin Diagnostic Clinic
Austin, Texas, United States
Countries
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References
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Salminen S, Endo A, Isolauri E, Scalabrin D. Early Gut Colonization With Lactobacilli and Staphylococcus in Infants: The Hygiene Hypothesis Extended. J Pediatr Gastroenterol Nutr. 2016 Jan;62(1):80-6. doi: 10.1097/MPG.0000000000000925.
Scalabrin DM, Mitmesser SH, Welling GW, Harris CL, Marunycz JD, Walker DC, Bos NA, Tolkko S, Salminen S, Vanderhoof JA. New prebiotic blend of polydextrose and galacto-oligosaccharides has a bifidogenic effect in young infants. J Pediatr Gastroenterol Nutr. 2012 Mar;54(3):343-52. doi: 10.1097/MPG.0b013e318237ed95.
Other Identifiers
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33715
Identifier Type: -
Identifier Source: org_study_id