Gastro-Intestinal Tolerance
Conditions
Brief summary
The purpose of this study is to evaluate growth and tolerance of healthy term infants fed an experimental milk-based infant formula with oligosaccharides compared to a control milk-based infant formula.
Interventions
Ready to feed infant formula, feed ad libitum
Ready to feed infant formula, feed ad libitum
OTHERReference Group
Human milk, breast feeding ad libitum
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 14 Days
Healthy volunteers
Yes
Inclusion criteria
* Good health as determined from participant's medical history * Singleton from a full-term birth with a gestational age of 37-42 weeks * Birth weight was \> 2490 g (\ 5 lbs. 8 oz.) * If parent(s) of the participant elect to formula-feed the participant, parent(s) confirm the participant has not been given human milk since being discharged from the hospital following birth, and confirm their intention to feed their infant the study product as the sole source of feeding from Study Visit 1-Visit 7, unless instructed otherwise by their healthcare professional. * If parent(s) of the participant elect to feed the infant human milk, they confirm the infant has not received any formula prior to enrollment, and confirm their intention to exclusively feed human milk from birth, and as the sole source of feeding from Study Visit 1-Visit 7. * Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional. * Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or other applicable privacy regulation) authorization prior to any participation in the study.
Exclusion criteria
* An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development. * Participant is taking and plans to continue taking medications (including over the counter (OTC), such as Mylicon® for gas), prebiotics, probiotics, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance. * Participant participates in another study that has not been approved as a concomitant study by AN.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | Day of life 14 - 119 | Weight gain per day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stool Characteristics | Study Day 1 to Day of life 119 | Parent completed diary |
| Formula Tolerance | Study Day 1 to Day of life 119 | Parent completed diary |
| Head Circumference (HC) | Study Day 1 to Day of life 119 | HC gain per day |
| Illness Incidence | Study Day 1 to Day of life 119 | Parent reported incidence of illness |
| Length | Study Day 1 to Day of life 119 | Length gain per day |
Other
| Measure | Time frame | Description |
|---|---|---|
| Stool Sample | Study Day 1 to Day of life 119 | Microbiota characterization |
Countries
United States
Outcome results
None listed