Alternate Formula Feedings in Formula Intolerant Infants

Efficacy of Alternate Formula Feedings in Formula Intolerant Infants

This study assessed tolerance improvement of a formula change in healthy term infants with perceived intolerance to their current milk-based formula feeding.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Tolerance
• Intervention / Treatment: Other: Infant Formula 1; Other: Infant Formula 2

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Oshawa, Canada, L1H
    • Optimum Clinical Research
• United States
  • Alaska
    • Little Rock, Alaska, United States, 72202
      • Arkansas Children's Hospital
  • Colorado
    • Aurora, Colorado, United States, 80011
      • Aurora Pediatric Associates
  • Georgia
    • Stone Mountain, Georgia, United States, 30087
      • Northlake Pediatric, Associates
  • Iowa
    • Dubuque, Iowa, United States, 52001
      • The Medical Associates Clinic
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center, Children's Hospital
  • Ohio
    • Canton, Ohio, United States, 44709
      • Clinical Studies, Inc
  • Virginia
    • Richmond, Virginia, United States, 23294
      • Richmond Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 2 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Infants formula-fed exclusively and experiencing symptoms of cow's milk formula intolerance.
• Infants whose physicians had made a recommendation that the parents change the infant's feeding.
• Full term infants at birth with a gestational age of 37 to 42 weeks.
• Infants 2- 9 weeks of age at study entry with birth weights greater than 2500 grams.

Exclusion Criteria:

• Infants with a maternal medical history which had adverse effects on the fetus, such as diabetes, tuberculosis, perinatal infections, or substance abuse.
• Infants with evidence of cardiac, respiratory, gastrointestinal, hematological, or metabolic disease.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Infant Formula 1; A standard commercial milk-based infant formula	Other: Infant Formula 1; Feed ab libitum
Experimental: Infant Formula 2; A standard commercial soy-based infant formula.	Other: Infant Formula 2; Feed ab libitum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool Characteristics	Parent questionnaire	Change from Baseline (Study Day 1) to Study Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Formula Intake	Parent questionnaire on volume consumed	Change from Baseline (Study Day 1) to Study Day 15
Incidence of spit up/vomiting	Parent questionnaire	Change from Baseline (Study Day 1) to Study Day 15
Weight	Measured weight at visits	Change from Baseline (Study Day 1) to Study Day 15

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: John Lasekan, MBA, Ph.D, CCRP, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start: August 1, 1996
• Primary Completion (Actual): June 1, 1997
• Study Completion (Actual): June 1, 1997

Study Registration Dates

• First Submitted: May 27, 2015
• First Submitted That Met QC Criteria: May 27, 2015
• First Posted (Estimate): May 29, 2015

Study Record Updates

• Last Update Posted (Estimate): May 29, 2015
• Last Update Submitted That Met QC Criteria: May 27, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: AH23