Infants Fed a Hydrolyzed Infant Formula

Abbott

Status

Completed

Conditions

Gastrointestinal Tolerance

Treatments

Other: Hydrolyzed protein infant formula with oligosaccharides

Study type

Interventional

Funder types

Industry

Identifiers

NCT05369494

AL49

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

All

Ages

Under 90 days old

Volunteers

No Healthy Volunteers

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