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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Tolerance
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36305
      • Alabama Clinical Therapeutics
  • Florida
    • Plantation, Florida, United States, 33324
      • All Women's Heatlthcare of West Broward, Inc: Discovery Clinical Research, Inc
    • St. Petersburg, Florida, United States, 33710
      • SCORE Physician Alliance, LLC
    • Tampa, Florida, United States, 33606
      • University of South Florida
  • Georgia
    • Dalton, Georgia, United States, 30721
      • North Georgia Clinical Research
  • Indiana
    • Indianapolis, Indiana, United States, 46038
      • Northpoint Pediatrics, LLC
  • Iowa
    • Dubuque, Iowa, United States, 52001
      • Medical Associates Clinic, PC
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • Kentucky Pediatric / Adult Research
  • Ohio
    • Cincinnati, Ohio, United States, 45245
      • Pediatric Associates of Mount Carmel, Inc
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
    • Dayton, Ohio, United States, 45406
      • Dayton Clinical Research
    • Huber Heights, Ohio, United States, 45424
      • Ohio Pediatric Research Association, Inc.
    • Mayfield Heights, Ohio, United States, 44124
      • Institute of Clinical Research
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • The Jackson Clinic, PA
  • Washington
    • Spokane, Washington, United States, 99218
      • Rockwood Clinic North - Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 week (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary variable is Gastrointestinal tolerance.	1-28 days of age

Secondary Outcome Measures

Outcome Measure	Time Frame
The secondary variables are additional measures of GI tolerance and parental feedback.	1-28 days of age

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (ACTUAL): January 1, 2010
• Study Completion (ACTUAL): January 1, 2010

Study Registration Dates

• First Submitted: September 15, 2009
• First Submitted That Met QC Criteria: September 15, 2009
• First Posted (ESTIMATE): September 16, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): November 25, 2010
• Last Update Submitted That Met QC Criteria: November 24, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: Infant
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Caseins
• Other Study ID Numbers: AK70