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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014