Gastrointestinal Tolerance Clinical Trial
Official title:
Efficacy of Alternate Formula Feedings in Formula Intolerant Infants
Verified date | May 2015 |
Source | Abbott Nutrition |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
This study assessed tolerance improvement of a formula change in healthy term infants with perceived intolerance to their current milk-based formula feeding.
Status | Completed |
Enrollment | 113 |
Est. completion date | June 1997 |
Est. primary completion date | June 1997 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 9 Weeks |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
Canada | Optimum Clinical Research | Oshawa | |
United States | Aurora Pediatric Associates | Aurora | Colorado |
United States | Clinical Studies, Inc | Canton | Ohio |
United States | The Medical Associates Clinic | Dubuque | Iowa |
United States | Arkansas Children's Hospital | Little Rock | Alaska |
United States | Richmond Pediatrics | Richmond | Virginia |
United States | Baystate Medical Center, Children's Hospital | Springfield | Massachusetts |
United States | Northlake Pediatric, Associates | Stone Mountain | Georgia |
Lead Sponsor | Collaborator |
---|---|
Abbott Nutrition |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Stool Characteristics | Parent questionnaire | Change from Baseline (Study Day 1) to Study Day 15 | No |
Secondary | Formula Intake | Parent questionnaire on volume consumed | Change from Baseline (Study Day 1) to Study Day 15 | No |
Secondary | Incidence of spit up/vomiting | Parent questionnaire | Change from Baseline (Study Day 1) to Study Day 15 | No |
Secondary | Weight | Measured weight at visits | Change from Baseline (Study Day 1) to Study Day 15 | No |
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