Tolerance and Compliance of Infants Fed an Hydrolyzed Infant Formula

Abbott

Status and phase

Completed

Phase 3

Conditions

Infant

Gastrointestinal Intolerance

Treatments

Other: Experimental Hydrolyzed infant formula

Study type

Interventional

Funder types

Industry

Identifiers

AK94

Details and patient eligibility

About

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

Enrollment

25 patients

Sex

All

Ages

Under 180 days old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Participation in another study