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The Effects on Growth of a Non-Routine Infant Formula

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ClinicalTrials.gov Identifier: NCT00655720
Recruitment Status : Completed
First Posted : April 10, 2008
Last Update Posted : April 15, 2008
Sponsor:
Information provided by:
Mead Johnson Nutrition

Brief Summary:
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 or disease Intervention/treatment Phase
Growth Other: infant formula Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 293 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: The Effects on Growth and Tolerance of Hydrolyzed Formulas Fed to Term Infants
Study Start Date : March 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Growth (weight) [ Time Frame: 106 days ]

Secondary Outcome Measures :
  1. Tolerance [ Time Frame: 106 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Days   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00655720


Sponsors and Collaborators
Mead Johnson Nutrition
Investigators
Study Director: Deolinda Scalabrin, MD Mead Johnson Nutrition

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
First Posted: April 10, 2008    Key Record Dates
Last Update Posted: April 15, 2008
Last Verified: April 2008

Keywords provided by Mead Johnson Nutrition:
infant formula