Tolerance and Compliance of Infants Fed an Extensively Hydrolyzed Infant Formula

Abbott Nutrition3 sites in 1 country25 target enrollmentFebruary 2012

Overview

The objective of the study is to assess gastrointestinal tolerance and compliance in infants who require a hydrolyzed formula.

Registry

clinicaltrials.gov

Start Date

February 2012

End Date

September 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Responsible Party

Sponsor

•Infant is 0 to 180 days of age
•Infant with persistent feeding intolerance symptoms; has had at least 1 formula switch OR infant is experiencing/being managed with an extensively hydrolyzed formula for suspected food protein intolerance or allergy or other condition where an extensively hydrolyzed formula is deemed appropriate
•Infant has not consumed an extensively hydrolyzed infant formula
•Use of prescription medications, OTC medications, home remedies, herbal preparations or rehydration fluids restricted
•Infant is not receiving steroids.
•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 through the duration of the study.
•Parent(s) confirm their intention not to administer vitamin or mineral during the study