Gastrointestinal Tolerance
Conditions
Brief summary
The purpose of this non-randomized, multi-center study is to evaluate the growth, tolerance and compliance of an extensively hydrolyzed infant formula in an intended use population of infants.
Interventions
OTHERHydrolyzed protein infant formula with oligosaccharides
Hydrolyzed protein infant formula with oligosaccharides
Sponsors
Abbott Nutrition
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Days to 90 Days
Healthy volunteers
No
Inclusion criteria
* Infant is 0 to 90 days of age at enrollment. * Formula-fed Infant who is either experiencing persistent feeding intolerance, symptoms of suspected food protein allergy or currently consuming an extensively hydrolyzed formula (EHF) for symptoms of suspected food protein allergy, persistent feeding intolerance symptoms or other conditions where EHF is deemed an appropriate feeding by their health care professional * Parent(s) of infants confirm their intention not to administer prescription medications, OTC medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect GI tolerance, unless their infants are currently consuming and have been directed by their healthcare professional to continue their use during the study * 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 from enrollment through the duration of the study * Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D supplements) to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional * Infant's parent(s) or a LAR has voluntarily signed and dated an informed consent form (ICF) approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (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 growth, and/or development * Awareness of a positive drug screen in the mother or participant * Suspected maternal substance abuse including alcohol * Participation in another study that has not been approved as a concomitant study by AN * Participant is receiving oral or inhaled steroids * Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent * Participant has received an amino acid-based formula
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Maintenance | Study Day1 to Study Day 28 | Change in weight for age z-score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal Tolerance | Study Day1 to Study Day 28 | Parent completed diary |
| Weight | Study Day1 to Study Day 28 | Weight gain per day in grams |
| Length | Study Day1 to Study Day 28 | Length gain per day in cm |
Other
| Measure | Time frame | Description |
|---|---|---|
| Parent Perspectives Questionnaire | Study Day1 to Study Day 28 | Parent completed questionnaire; 4, 5-point Likert scale questions, scaled from negative to positive with higher scores indicating better perception |
| Adverse Events | Study Day1 to Study Day 28 | Parent reported adverse events |
| Formula Satisfaction Questionnaire | Study Day1 to Study Day 28 | Parent completed questionnaire; 13 questions of up to 5 categories, scaled from positive to negative |
| Infant Feeding and Stool Patterns Questionnaire | Study Day1 to Study Day 28 | Parent completed questionnaire; 16, 5-point Likert scale questions, scaled from always to never |
| Health Care Utilization | Study Day1 to Study Day 28 | Number of Visits |
Countries
United States
Outcome results
None listed