- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00503789
The Effect of Infant Feeding on Stool Characteristics
September 4, 2008 updated by: Mead Johnson Nutrition
Infants will be fed infant formula and stool characteristics assessed.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
280
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arkansas
-
Benton, Arkansas, United States, 72019
- Central Arkansas Pediatric Clinic
-
Conway, Arkansas, United States, 22401
- Arkansas Pediatrics of Conway
-
Jonesboro, Arkansas, United States, 72401
- The Children's Clinic of Jonesboro
-
-
Florida
-
Altamonte Springs, Florida, United States, 32701
- Altamonte Pediatric Associates
-
-
Illinois
-
Park Ridge, Illinois, United States, 60068
- Advocate Center for Pediatric Research
-
-
Indiana
-
Fishers, Indiana, United States, 46038
- Internal Medicine and Pediatrics
-
Indianapolis, Indiana, United States, 46229
- East Washington Pediatrics
-
-
Iowa
-
Coralville, Iowa, United States, 52241
- Children's Hospital of Iowa
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- University of Kansas Medical University
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- PTCU/Children and Youth Project
-
-
Louisiana
-
Bossier City, Louisiana, United States, 71111
- ACC Pediatric Research
-
-
Michigan
-
Kalamazoo, Michigan, United States, 49008
- ProMed HealthCare
-
Portage, Michigan, United States, 49024
- ProMed Pediatrics
-
Richland, Michigan, United States, 49083
- ProMed Physicians-Pediatrics
-
-
Nebraska
-
Omaha, Nebraska, United States, 68105
- The Center for Human Nutrition
-
-
New York
-
Mineola, New York, United States, 11501
- Winthrop Pediatric Associates
-
-
North Carolina
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Cary, North Carolina, United States, 27511
- Cary Pediatric Center, P.A.
-
-
Ohio
-
Cincinnati, Ohio, United States, 45245
- Pediatric Associates of Mt. Carmel, Inc.
-
Fairfield, Ohio, United States, 45014
- Pediatric Associates of Fairfield, Inc.
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Mason, Ohio, United States, 45040
- Northeast Cincinnati Pediatric Assoc
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19114
- Red Lion Pediatrics
-
-
Tennessee
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Clarksville, Tennessee, United States, 37043
- Alpha Clinical Research
-
-
Texas
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Austin, Texas, United States, 78745
- Austin Diagnostic Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 weeks to 1 month (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy, term infants
- 21-30 days of age
Exclusion Criteria:
- Infants with feeding difficulties
- Use of antibiotics or steroids
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
cow-milk based infant formula
|
ad lib feeding
|
Experimental: 2
cow milk based infant formula with prebiotics
|
ad lib feeding
|
Other: 3
human milk reference group
|
ad lib feeding
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
fecal bacteria analysis
Time Frame: 60 days
|
60 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intake, tolerance, stool characteristics, anthropometrics
Time Frame: 60 days
|
60 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Deolinda Scalabrin, MD, Mead Johnson Nutrition
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
July 17, 2007
First Submitted That Met QC Criteria
July 18, 2007
First Posted (Estimate)
July 19, 2007
Study Record Updates
Last Update Posted (Estimate)
September 5, 2008
Last Update Submitted That Met QC Criteria
September 4, 2008
Last Verified
September 1, 2008
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 33715
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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