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The Effects on Growth of a Non-Routine Infant Formula

This study has been completed.
Sponsor:
Information provided by:
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT00655720
First received: March 28, 2008
Last updated: April 10, 2008
Last verified: April 2008
History of Changes
  Purpose

A study to evaluate the growth and development of term infants fed either an extensively hydrolyzed formula with probiotics, a partially hydrolyzed formula with probiotics, or an extensively hydrolyzed formula without probiotics


Condition Intervention
Growth
 Other: infant formula

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: The Effects on Growth and Tolerance of Hydrolyzed Formulas Fed to Term Infants

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mead Johnson Nutrition:

Primary Outcome Measures:
  • Growth (weight) [ Time Frame: 106 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tolerance [ Time Frame: 106 days ] [ Designated as safety issue: No ]

Enrollment: 293
Study Start Date: March 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Other: infant formula
  1. hydrolyzed infant formula without probiotics
  2. hydrolyzed infant formula with probiotics
  3. hydrolyzed infant formula with probiotics
Other Name: no other names for any of the intervention arms
Experimental: 2 Other: infant formula
  1. hydrolyzed infant formula without probiotics
  2. hydrolyzed infant formula with probiotics
  3. hydrolyzed infant formula with probiotics
Other Name: no other names for any of the intervention arms
Experimental: 3 Other: infant formula
  1. hydrolyzed infant formula without probiotics
  2. hydrolyzed infant formula with probiotics
  3. hydrolyzed infant formula with probiotics
Other Name: no other names for any of the intervention arms

  Eligibility

Ages Eligible for Study:   up to 16 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Term infant
  • Solely formula fed
  • 14 days of age

Exclusion Criteria:

  • History of underlying disease
  • Evidence of formula intolerance
  • Current illness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00655720

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: Kim Merkel, Mead Johnson
ClinicalTrials.gov Identifier: NCT00655720     History of Changes
Other Study ID Numbers: 3369-5, 3369-5
Study First Received: March 28, 2008
Last Updated: April 10, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Mead Johnson Nutrition:
infant formula

ClinicalTrials.gov processed this record on May 23, 2013