Tolerance of Healthy Term Infants Fed Infant Formulas - Full Text View

Purpose

The objective of the study is to assess comparative gastrointestinal tolerance of normal term infants to various milk-protein infant formulas.

Condition	Intervention	Phase
Infant, Newborn	Other: milk protein formulas, varying carbohydrate/protein sources	Phase II

MedlinePlus related topics:

Infant and Toddler Nutrition

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Official Title:	Tolerance of Healthy Term Infants Fed Infant Formulas

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:

Gastrointestinal tolerance [ Time Frame: 0-8 days of age until 28 days of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

GI and intake parameters [ Time Frame: 0-8 to 28 days of age ] [ Designated as safety issue: No ]

Estimated Enrollment:	185
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Experimental milk protein based infant formula with varying carbohydrate and protein source	Other: milk protein formulas, varying carbohydrate/protein sources ad lib for 0-8 days of age until 28 days of age
2: Experimental Experimental milk protein based infant formula with varying carbohydrate and protein source	Other: milk protein formulas, varying carbohydrate/protein sources ad lib for 0-8 days of age until 28 days of age
3: Experimental Experimental milk protein based infant formula with varying carbohydrate and protein source	Other: milk protein formulas, varying carbohydrate/protein sources ad lib for 0-8 days of age until 28 days of age
4: Experimental Experimental milk protein based infant formula with varying carbohydrate and protein source	Other: milk protein formulas, varying carbohydrate/protein sources ad lib for 0-8 days of age until 28 days of age
5: Experimental Experimental milk protein based infant formula with varying carbohydrate and protein source	Other: milk protein formulas, varying carbohydrate/protein sources ad lib for 0-8 days of age until 28 days of age

Eligibility

Ages Eligible for Study:	up to 8 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy, term infants; singleton birth; 37-42 weeks of age; >2490gms at birth; 0-8 days of age

Exclusion Criteria:

medications/foods/formulas affecting GI tolerance;adverse medical history with possible effect on tolerance or growth

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705562

Contacts


Contact: Bobbie L Swearengin, RN	614 624 7182	Bobbie.Swearengin@abbott.com

Locations


United States, Florida
	University of South Florida	Not yet recruiting
	Tampa, Florida, United States, 33606
	Principal Investigator: Terri Ashmeade, MD
	Global Clinical Investigation	Not yet recruiting
	Aventura, Florida, United States, 33180
	Principal Investigator: Harold Deulofeut, MD

United States, Iowa
	Medical Associates Clinic	Recruiting
	Dubuque, Iowa, United States, 52002
	Principal Investigator: Kevin Mullen, MD
	University of Iowa	Not yet recruiting
	Coralville, Iowa, United States, 52241
	Principal Investigator: Ekhard Ziegler, MD

United States, Kentucky
	Kentucky Pediatric Research	Recruiting
	Bardstown, Kentucky, United States, 40004
	Principal Investigator: James Hedrick, MD
	PediaResearch, Inc	Recruiting
	Owensboro, Kentucky, United States, 42301
	Principal Investigator: Richard Litov, PhD

United States, Maryland
	University of Maryland	Recruiting
	Baltimore, Maryland, United States, 21201
	Principal Investigator: Susan Feigelman, MD

United States, Nebraska
	Midwest Children's Health Research Institute, LLC	Recruiting
	Lincoln, Nebraska, United States, 68504
	Principal Investigator: Patrick O'Grady, MD
	The Center for Human Nutrition	Not yet recruiting
	Omaha, Nebraska, United States, 68105
	Principal Investigator: Sheryl Pitner, MD

United States, Ohio
	MetroHealth Medical Center	Not yet recruiting
	Cleveland, Ohio, United States, 44109
	Principal Investigator: Sharon Groh-Wargo, PhD
	Institute of Clinical Research	Recruiting
	Mayfield Heights, Ohio, United States, 44124
	Principal Investigator: James Guerrieri, MD
	Ohio Pediatric Research Association	Recruiting
	Huber Heights, Ohio, United States, 45424
	Principal Investigator: Julie Shepard, MD
	Pediatric Associates of Fairfield	Not yet recruiting
	Fairfield, Ohio, United States, 45014
	Principal Investigator: Warren Webb, MD

United States, Pennsylvania
	Primary Physicians Research, Inc	Not yet recruiting
	Pittsburgh, Pennsylvania, United States, 15241
	Principal Investigator: Mark Blatter, MD

United States, West Virginia
	West Virginia University	Not yet recruiting
	Morgantown, West Virginia, United States, 26506
	Principal Investigator: Mark Polak, MD

Sponsors and Collaborators

Abbott Nutrition

Investigators


Study Director:	Steven Davis, PhD	Abbott Nutrition

More Information

Responsible Party:	Abbott Nutrition ( Bobbie Swearengin )
Study ID Numbers:	AK62
First Received:	June 24, 2008
Last Updated:	July 1, 2008
ClinicalTrials.gov Identifier:	NCT00705562
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	Abbott Nutrition
Information provided by:	Abbott Nutrition
ClinicalTrials.gov Identifier:	NCT00705562