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NCT01573871 Clinical Trial

Tolerance and Compliance of Infants Fed an Hydrolyzed Infant Formula

Infant Clinical Trial

Official title:
Tolerance and Compliance of Infants Fed an Extensively Hydrolyzed Infant Formula

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01573871
Other study ID # AK94
Secondary ID
Status Completed
Phase Phase 3
First received April 6, 2012
Last updated February 14, 2013
Start date February 2012
Est. completion date September 2012

Study information
Verified date February 2013
Source Abbott Nutrition
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group N/A to 180 Days
Eligibility 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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Experimental Hydrolyzed infant formula
Experimental hydrolyzed infant formula to be fed ad libitum

Locations
Country Name City State
United States Metro-Health Medical Center Cleveland Ohio
United States Ohio Pediatric Research Association Huber Heights Ohio
United States Northpoint Pediatrics Indianapolis Indiana

Sponsors (1)
Lead Sponsor Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Weight maintenance 14 days No
Secondary Formula volume intake 14 days No
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