Tolerance and Compliance of Infants Fed an Hydrolyzed Infant Formula

Phase 3

Completed

• Conditions: Infant; Gastrointestinal Intolerance
• Interventions: Other: Experimental Hydrolyzed infant formula

• Registration Number: NCT01573871
• Lead Sponsor: Abbott Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-04-06
• Study First Submitted QC: 2012-04-06
• Study First Posted: 2012-04-10
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-14
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hydrolyzed infant formula	Experimental Hydrolyzed infant formula	Hydrolyzed infant formula to be fed ad libitum

Primary Outcome Measures

Name	Time	Method
Weight maintenance	14 days

Secondary Outcome Measures

Name	Time	Method
Formula volume intake	14 days

Trial Locations

Locations (3)

Northpoint Pediatrics; 🇺🇸 Indianapolis, Indiana, United States

Metro-Health Medical Center; 🇺🇸 Cleveland, Ohio, United States

Ohio Pediatric Research Association; 🇺🇸 Huber Heights, Ohio, United States