Healthy
Conditions
Keywords
Healthy term infants
Brief summary
To assess the gastrointestinal tolerance of healthy full-term infants fed either experimental formula or a control formula
Interventions
OTHERMilk based formula A
feed as per HCP directions
OTHER#2 Standard formula
Feed as per HCP directions
OTHER#3 Human Milk
Feed as per HCP directions
OTHERMilk based formula C
Feed as per HCP direction
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 8 Days
Healthy volunteers
Yes
Inclusion criteria
* judged to be in good health. * singleton from a full term birth with a gestational age of 37-42 weeks * birth weight was \> 2490 g (\ 5 lbs 8 oz) * between 0 and 8 days of age at enrollment. * Infant's parent(s) or a LAR has voluntarily signed and dated an ICF, approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.
Exclusion criteria
* An adverse maternal, fetal or infant medical history thought by the investigator to have potential for effects on tolerance, growth, and/or development, including, but not limited to suspected maternal substance abuse. * Infant has been treated with antibiotics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean rank stool consistency (MRSC) | Study Day 1 to Visit 3 |
Secondary
| Measure | Time frame |
|---|---|
| MRSC, percent watery stools, average number of stools per day, percent of feedings with spit-up and/or vomiting | 4 months |
Countries
United States
Outcome results
None listed