Alternate Formula Feedings in Formula Intolerant Infants
Efficacy of Alternate Formula Feedings in Formula Intolerant Infants
1 other identifier
interventional
113
2 countries
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 1996
Shorter than P25 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 1996
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 1997
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 1997
CompletedFirst Submitted
Initial submission to the registry
May 27, 2015
CompletedFirst Posted
Study publicly available on registry
May 29, 2015
CompletedMay 29, 2015
May 1, 2015
10 months
May 27, 2015
May 27, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Stool Characteristics
Parent questionnaire
Change from Baseline (Study Day 1) to Study Day 15
Secondary Outcomes (3)
Formula Intake
Change from Baseline (Study Day 1) to Study Day 15
Incidence of spit up/vomiting
Change from Baseline (Study Day 1) to Study Day 15
Weight
Change from Baseline (Study Day 1) to Study Day 15
Study Arms (2)
Infant Formula 1
ACTIVE COMPARATORA standard commercial milk-based infant formula
Infant Formula 2
EXPERIMENTALA standard commercial soy-based infant formula.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (8)
Arkansas Children's Hospital
Little Rock, Alaska, 72202, United States
Aurora Pediatric Associates
Aurora, Colorado, 80011, United States
Northlake Pediatric, Associates
Stone Mountain, Georgia, 30087, United States
The Medical Associates Clinic
Dubuque, Iowa, 52001, United States
Baystate Medical Center, Children's Hospital
Springfield, Massachusetts, 01199, United States
Clinical Studies, Inc
Canton, Ohio, 44709, United States
Richmond Pediatrics
Richmond, Virginia, 23294, United States
Optimum Clinical Research
Oshawa, L1H, Canada
Study Officials
- STUDY CHAIR
John Lasekan, MBA, Ph.D, CCRP
Abbott Nutrition
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2015
First Posted
May 29, 2015
Study Start
August 1, 1996
Primary Completion
June 1, 1997
Study Completion
June 1, 1997
Last Updated
May 29, 2015
Record last verified: 2015-05