Healthy Term Infants
Conditions
Brief summary
The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental powdered formulas compared with a commercially available powdered formula.
Interventions
OTHERHydrolysate based infant formula
Infant formula ad lib
OTHERInvestigational Infant Formula A
Investigational infant formula ad lib
OTHERInvestigational Infant Formula B
Investigational infant formula ad lib
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
1 Days to 8 Days
Healthy volunteers
Yes
Inclusion criteria
* Singleton full term birth in good health * Birth weight was \> 2490 g. * Between 0 and 8 days of age. * Infants using medications (including OTC such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled unless both the parent and the physician agree to discontinue these agents prior to enrollment. * Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study, unless instructed otherwise by their healthcare professional. * Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study.
Exclusion criteria
• An adverse maternal, fetal or infant medical history and treatment with antibiotics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GI tolerance via stool consistency | 28 days |
Countries
United States
Outcome results
None listed