Gastrointestinal Tolerance
Conditions
Brief summary
This is a prospective, randomized, multicenter study to assess the tolerance of infant formulas.
Interventions
OTHERHydrolysate Infant Formula 1
Feed ad lib
OTHERHydrolysate Infant Formula 2
Feed ad lib
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 14 Days
Healthy volunteers
Yes
Inclusion criteria
* Subject is judged to be in good health * Singleton from a full-term birth * Birth weight was \> or = to 2490 g * Between 0 and 14 days of age at enrollment * Parent(s) confirm their intention to feed their infant the assigned study product as the sole source of nutrition for the duration of the study * 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 * Subject's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF)
Exclusion criteria
* An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development. * Subject is taking and plans to continue medications, home remedies, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance * Subject participates in another study that has not been approved as a concomitant study * Subject has an allergy or intolerance to any ingredient in the study product * Subject has been treated with antibiotics within 2 weeks prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stool Characteristics | Study Day 1 - Study Day 21 | Parent completed diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Formula Intake | Study Day 1 - Study Day 21 | Parent completed diary |
| Weight | Study Day 1 - Study Day 21 | Scale |
| Length | Study Day 1 - Study Day 21 | Length board |
Countries
United States
Outcome results
None listed