Alternate Formula Feedings in Formula Intolerant Infants

Not Applicable

Completed

• Conditions: Gastrointestinal Tolerance
• Interventions: Other: Infant Formula 1; Other: Infant Formula 2

• Registration Number: NCT02456805
• Lead Sponsor: Abbott Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1996-08
• Primary Completion: 1997-06
• Study Completion: 1997-06
• Status Verified: 2015-05
• Study First Submitted: 2015-05-27
• Study First Submitted QC: 2015-05-27
• Last Update Submitted: 2015-05-27
• Study First Posted: 2015-05-29
• Last Update Posted: 2015-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infant Formula 1	Infant Formula 1	A standard commercial milk-based infant formula
Infant Formula 2	Infant Formula 2	A standard commercial soy-based infant formula.

Primary Outcome Measures

Name	Time	Method
Stool Characteristics	Change from Baseline (Study Day 1) to Study Day 15	Parent questionnaire

Secondary Outcome Measures

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

Trial Locations

Locations (8)

Arkansas Children's Hospital; 🇺🇸 Little Rock, Alaska, United States

Aurora Pediatric Associates; 🇺🇸 Aurora, Colorado, United States

The Medical Associates Clinic; 🇺🇸 Dubuque, Iowa, United States

Northlake Pediatric, Associates; 🇺🇸 Stone Mountain, Georgia, United States

Richmond Pediatrics; 🇺🇸 Richmond, Virginia, United States

Clinical Studies, Inc; 🇺🇸 Canton, Ohio, United States

Optimum Clinical Research; 🇨🇦 Oshawa, Canada

Baystate Medical Center, Children's Hospital; 🇺🇸 Springfield, Massachusetts, United States