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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
History of Changes

September 15, 2009
November 24, 2010
September 2009
January 2010   (final data collection date for primary outcome measure)
The primary variable is Gastrointestinal tolerance. [ Time Frame: 1-28 days of age ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00977964 on ClinicalTrials.gov Archive Site
The secondary variables are additional measures of GI tolerance and parental feedback. [ Time Frame: 1-28 days of age ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Tolerance of Healthy Term Infants Fed Infant Formulas #3
Tolerance of Healthy Term Infants Fed Infant Formulas

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Gastrointestinal Tolerance
  • Other: Experimental milk protein infant formula Process A
    ad lib for 1-8 days of age until 28 days of age
  • Other: Experimental milk protein infant formula Process B
    ad lib from 1-8 days of age until 28 days of age
  • Other: Experimental milk protein infant formula Process C
    ad lib from 1-8 days of age to 28 days of age
  • Other: Experimental milk protein infant formula Process D
    ad lib from 1-8 days of age until 28 days of age
  • Other: Experimental milk protein infant formula Process E
    ad lib from 1-8 days of age until 28 days of age
  • Other: Experimental milk protein infant formula Process F
    ad lib from 1-8 days of age until 28 days of age
  • Experimental: Milk Based Protein Formula Process A
    Intervention: Other: Experimental milk protein infant formula Process A
  • Experimental: Milk Based Protein Formula Process B
    Intervention: Other: Experimental milk protein infant formula Process B
  • Experimental: Milk Based Protein Formula Process C
    Intervention: Other: Experimental milk protein infant formula Process C
  • Experimental: Milk Based Protein Formula Process D
    Intervention: Other: Experimental milk protein infant formula Process D
  • Experimental: Milk Based Protein Formula Process E
    Intervention: Other: Experimental milk protein infant formula Process E
  • Experimental: Milk Based Protein Formula Process F
    Intervention: Other: Experimental milk protein infant formula Process F
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
270
January 2010
January 2010   (final data collection date for primary outcome measure)

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.
Both
up to 8 Days
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00977964
AK70
Yes
Bobbie L Swearengin, RN, Abbott Nutrition
Abbott Nutrition
Not Provided
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
Abbott Nutrition
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP