Gastrointestinal Intolerance, Infant
Conditions
Brief summary
The objective of the study is to assess gastrointestinal tolerance and compliance in infants who require a hydrolyzed formula.
Interventions
OTHERExperimental Hydrolyzed infant formula
Experimental hydrolyzed infant formula to be fed ad libitum
Sponsors
Abbott Nutrition
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 180 Days
Healthy volunteers
No
Inclusion criteria
* Infant is 0 to 180 days of age * Infant with persistent feeding intolerance symptoms; has had at least 1 formula switch OR infant is experiencing/being managed with an extensively hydrolyzed formula for suspected food protein intolerance or allergy or other condition where an extensively hydrolyzed formula is deemed appropriate * Infant has not consumed an extensively hydrolyzed infant formula * Use of prescription medications, OTC medications, home remedies, herbal preparations or rehydration fluids restricted * Infant is not receiving steroids. * Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study * Parent(s) confirm their intention not to administer solid foods or juices to their infant through the duration of the study. * Parent(s) confirm their intention not to administer vitamin or mineral during the study
Exclusion criteria
• Participation in another study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight maintenance | 14 days |
Secondary
| Measure | Time frame |
|---|---|
| Formula volume intake | 14 days |
Countries
United States
Outcome results
None listed