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Tolerance of Healthy Term Infants Fed Infant Formulas #3

This study has been completed.
Sponsor:
Information provided by:
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT00977964
First received: September 15, 2009
Last updated: November 24, 2010
Last verified: November 2010
  Purpose

The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to six experimental milk protein-based powdered infant formulas.


Condition Intervention Phase
Gastrointestinal Tolerance
Other: Experimental milk protein infant formula Process A
Other: Experimental milk protein infant formula Process B
Other: Experimental milk protein infant formula Process C
Other: Experimental milk protein infant formula Process D
Other: Experimental milk protein infant formula Process E
Other: Experimental milk protein infant formula Process F
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tolerance of Healthy Term Infants Fed Infant Formulas

Resource links provided by NLM:


Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • The primary variable is Gastrointestinal tolerance. [ Time Frame: 1-28 days of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary variables are additional measures of GI tolerance and parental feedback. [ Time Frame: 1-28 days of age ] [ Designated as safety issue: No ]

Enrollment: 270
Study Start Date: September 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Milk Based Protein Formula Process A Other: Experimental milk protein infant formula Process A
ad lib for 1-8 days of age until 28 days of age
Experimental: Milk Based Protein Formula Process B Other: Experimental milk protein infant formula Process B
ad lib from 1-8 days of age until 28 days of age
Experimental: Milk Based Protein Formula Process C Other: Experimental milk protein infant formula Process C
ad lib from 1-8 days of age to 28 days of age
Experimental: Milk Based Protein Formula Process D Other: Experimental milk protein infant formula Process D
ad lib from 1-8 days of age until 28 days of age
Experimental: Milk Based Protein Formula Process E Other: Experimental milk protein infant formula Process E
ad lib from 1-8 days of age until 28 days of age
Experimental: Milk Based Protein Formula Process F Other: Experimental milk protein infant formula Process F
ad lib from 1-8 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:

  • Infant is judged to be in good health.
  • Infant is a singleton from a full term birth.
  • Infant's birth weight was > 2490 g (~5 lbs 8 oz.
  • Infant is between 0 and 8 days of age at enrollment.
  • Infants using medications, home remedies ,herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled.
  • Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional.

Exclusion Criteria:

  • An adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
  • Infant has been treated with antibiotics.
  • Infant has received probiotics.
  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: NCT00977964

Locations
United States, Alabama
Alabama Clinical Therapeutics
Dothan, Alabama, United States, 36305
United States, Florida
All Women's Heatlthcare of West Broward, Inc: Discovery Clinical Research, Inc
Plantation, Florida, United States, 33324
SCORE Physician Alliance, LLC
St. Petersburg, Florida, United States, 33710
University of South Florida
Tampa, Florida, United States, 33606
United States, Georgia
North Georgia Clinical Research
Dalton, Georgia, United States, 30721
United States, Indiana
Northpoint Pediatrics, LLC
Indianapolis, Indiana, United States, 46038
United States, Iowa
Medical Associates Clinic, PC
Dubuque, Iowa, United States, 52001
United States, Kentucky
Kentucky Pediatric / Adult Research
Bardstown, Kentucky, United States, 40004
United States, Ohio
Pediatric Associates of Mount Carmel, Inc
Cincinnati, Ohio, United States, 45245
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Dayton Clinical Research
Dayton, Ohio, United States, 45406
Ohio Pediatric Research Association, Inc.
Huber Heights, Ohio, United States, 45424
Institute of Clinical Research
Mayfield Heights, Ohio, United States, 44124
United States, Tennessee
The Jackson Clinic, PA
Jackson, Tennessee, United States, 38305
United States, Washington
Rockwood Clinic North - Pediatrics
Spokane, Washington, United States, 99218
Sponsors and Collaborators
Abbott Nutrition
Investigators
Principal Investigator: Caude T Ashley, MD Alabama Clinical Therapeutics, LLC
Principal Investigator: Terri L Ashmeade, MD USF Department of Pediatrics
Principal Investigator: Jay Cohen, MD Discovery Clinical Research, Inc.
Principal Investigator: Timothy Crum, MD Rockwood Clinic
Principal Investigator: Cole Ezeoke, MD North Georgia Clinical Research, White's Pediatrics
Principal Investigator: Sharon Groh-Wargo, PhD, RD, LD MetroHealth Medical Center
Principal Investigator: James Guerrieri, MD Institute of Clinical Research, LLC
Principal Investigator: James Hedrick, MD Kentucky Pediatric Research
Principal Investigator: Jeffrey Hirschfield, MD SCORE Physician Alliance, LLC
Principal Investigator: Kevin Mullen, MD Medical Associates Clinic, PC
Principal Investigator: Chris Peltier, MD Pediatric Associates of Mount Carmel, Inc.
Principal Investigator: Martin J Schear, MD Dayton Clinical Research
Principal Investigator: Julie Shepard, MD Ohio Pediatric Research Association
Principal Investigator: William Stepp, MD Sarah Cannon Research Institute, LLC
Principal Investigator: L Louise Tetrick, MD Northpoint Pediatrics
  More Information

No publications provided

Responsible Party: Bobbie L Swearengin, RN, Abbott Nutrition
ClinicalTrials.gov Identifier: NCT00977964     History of Changes
Other Study ID Numbers: AK70
Study First Received: September 15, 2009
Last Updated: November 24, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Abbott Nutrition:
Infant

ClinicalTrials.gov processed this record on November 27, 2014