Gastrointestinal Tolerance
Conditions
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.
Interventions
OTHERInfant Formula 1
Feed ab libitum
OTHERInfant Formula 2
Feed ab libitum
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Weeks to 9 Weeks
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stool Characteristics | Change from Baseline (Study Day 1) to Study Day 15 | Parent questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Weight | Change from Baseline (Study Day 1) to Study Day 15 | Measured weight at visits |
Countries
Canada, United States
Outcome results
None listed