Protein Intolerance
Conditions
Brief summary
This is a single group, non-randomized, multicenter study to assess the effects of a hypoallergenic casein hydrolysate powdered infant formula on gastrointestinal (GI) tolerance, growth and compliance in an intended use infant population.
Interventions
OTHERExperimental Hydrolyzed Protein Infant Formula
fed ad libitum
Sponsors
Abbott Nutrition
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 60 Days
Healthy volunteers
No
Inclusion criteria
* Participant is presently consuming an extensively hydrolyzed infant formula (EHF) for persistent feeding intolerance symptoms, symptoms of suspected food protein (milk and/or soy) sensitivity, or other conditions where EHF is deemed an appropriate feeding. * Parent(s) of infants confirm their intention not to administer prescription medications, over the counter medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect GI tolerance. * 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 vitamins, minerals (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study. * Participant's parent(s) or a legally authorized representative (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. * Participant is receiving oral or inhaled steroids. * Participant participates in another study that has not been approved as a concomitant study. * Participant has an allergy or intolerance to any ingredient in the study product. * Participant has been treated with antibiotics or other medications that in the opinion of the PI may affect growth, GI tolerance and/or development, within 2 weeks prior to enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight for Age | Study Day 1 to Study Day 60 | Change in weight for age z-score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal Tolerance | Study Day 1 to Study Day 60 | Parent completed diary questions |
| Length | Study Day 1 to Study Day 60 | Gain measured in cm |
| Head Circumference | Study Day 1 to Study Day 60 | Gain measured in cm |
Countries
United States
Outcome results
None listed