The Effects on Growth of a Non-Routine Infant Formula - Full Text View

Sponsored by:	Mead Johnson
Information provided by:	Mead Johnson
ClinicalTrials.gov Identifier:	NCT00655720

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

MedlinePlus related topics: Infant and Toddler Nutrition

U.S. FDA Resources

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

Further study details as provided by Mead Johnson:

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
1: Active Comparator	Other: infant formula hydrolyzed infant formula without probiotics hydrolyzed infant formula with probiotics hydrolyzed infant formula with probiotics
2: Experimental	Other: infant formula hydrolyzed infant formula without probiotics hydrolyzed infant formula with probiotics hydrolyzed infant formula with probiotics
3: Experimental	Other: infant formula hydrolyzed infant formula without probiotics hydrolyzed infant formula with probiotics hydrolyzed infant formula with probiotics

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

Investigators

Study Director:

Deolinda Scalabrin, MD

Mead Johnson

More Information

No publications provided

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

Keywords provided by Mead Johnson:

infant formula

ClinicalTrials.gov processed this record on May 07, 2009