The Effect of Infant Feeding on Stool Characteristics

This study has been completed.
Sponsor:
Information provided by:
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT00503789
First received: July 17, 2007
Last updated: September 4, 2008
Last verified: September 2008
  Purpose

Infants will be fed infant formula and stool characteristics assessed.


Condition Intervention
Healthy
Procedure: fecal bacteria analysis

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: The Effect of Infant Feeding on Stool Characteristics

Resource links provided by NLM:


Further study details as provided by Mead Johnson Nutrition:

Primary Outcome Measures:
  • fecal bacteria analysis [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intake, tolerance, stool characteristics, anthropometrics [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 280
Study Start Date: August 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
cow-milk based infant formula
Procedure: fecal bacteria analysis
ad lib feeding
Experimental: 2
cow milk based infant formula with prebiotics
Procedure: fecal bacteria analysis
ad lib feeding
3
human milk reference group
Procedure: fecal bacteria analysis
ad lib feeding

  Eligibility

Ages Eligible for Study:   up to 30 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, term infants
  • 21-30 days of age

Exclusion Criteria:

  • Infants with feeding difficulties
  • Use of antibiotics or steroids
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00503789

  Show 23 Study Locations
Sponsors and Collaborators
Mead Johnson Nutrition
Investigators
Study Director: Deolinda Scalabrin, MD Mead Johnson Nutrition
  More Information

No publications provided by Mead Johnson Nutrition

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Deolinda Scalabrin, Mead Johnson
ClinicalTrials.gov Identifier: NCT00503789     History of Changes
Other Study ID Numbers: 33715
Study First Received: July 17, 2007
Last Updated: September 4, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Mead Johnson Nutrition:
Healthy infants

ClinicalTrials.gov processed this record on April 17, 2014