Tolerance, Compliance and Growth of Infants Fed an Extensively Hydrolyzed Infant Formula With Added Human Milk Oligosaccharides

Abbott Nutrition6 sites in 1 country48 target enrollmentMarch 25, 2019

ConditionsProtein Intolerance

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Protein Intolerance
Sponsor: Abbott Nutrition
Enrollment: 48
Locations: 6
Primary Endpoint: Weight for Age
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 25, 2019

End Date

January 7, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Abbott Nutrition

Responsible Party

Sponsor

Eligibility Criteria

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.