Evaluation of Infants Fed an Extensively Hydrolyzed Infant Formula

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.