Tolerance and Compliance of Infants Fed an Hydrolyzed Infant Formula

Completed · Phase 3

Conditions studied: Infant, Gastrointestinal Intolerance

In brief

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

Key facts

Study ID

NCT01573871

Run by

Abbott Nutrition

People needed

25

Starts

2012-02-01

Expected to finish

2012-09-01

Last updated by the study team

2013-02-15

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Participation in another study

Where it is running

• Northpoint Pediatrics — Indianapolis, Indiana, United States
• Metro-Health Medical Center — Cleveland, Ohio, United States
• Ohio Pediatric Research Association — Huber Heights, Ohio, United States

Full record on ClinicalTrials.gov

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