Feeding Intolerance
Conditions
Brief summary
This is a non-randomized, single-group, multi-center, two phased study to evaluate formula intolerance.
Interventions
OTHERPartially Hydrolyzed Infant Formula
Commercially available infant formula
Sponsors
Abbott Nutrition
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 60 Days
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria for Stage 1: * Singleton full term birth with birth weight of \> 2500g. * Infant between 0 and 60 days of age. * Discontinuation of medications that might affect gastrointestinal (GI) tolerance. * Infant is exclusively formula-fed a full-lactose, intact cow milk protein-based infant formula (CMF) for less than 7 days prior to enrollment. Inclusion Criteria for Stage 2: * Infant was fed according to protocol in Stage 1 of the study. * Infant was identified as being fussy using the Intolerance Assessment Tool in Stage 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Fussiness | 0 to 15 days | Study phase 2; Parent completed questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diarrhea | 0 to 4 weeks | Study phase 1; Parent completed questionnaire. |
| Constipation | 0 to 4 weeks | Study phase 1; Parent completed questionnaire. |
| Spit-up | 0 to 4 weeks | Study phase 1; Parent completed questionnaire. |
| Gassiness | 0 to 4 weeks | Study phase 1; Parent completed questionnaire. |
Countries
China
Outcome results
None listed