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Tolerance and Compliance of Infants Fed an Hydrolyzed Infant Formula

This study has been completed.
Information provided by (Responsible Party):
Abbott Nutrition Identifier:
First received: April 6, 2012
Last updated: February 14, 2013
Last verified: February 2013
The objective of the study is to assess gastrointestinal tolerance and compliance in infants who require a hydrolyzed formula.

Condition Intervention Phase
Infant Gastrointestinal Intolerance Other: Experimental Hydrolyzed infant formula Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tolerance and Compliance of Infants Fed an Extensively Hydrolyzed Infant Formula

Resource links provided by NLM:

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Weight maintenance [ Time Frame: 14 days ]

Secondary Outcome Measures:
  • Formula volume intake [ Time Frame: 14 days ]

Enrollment: 25
Study Start Date: February 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hydrolyzed infant formula
Hydrolyzed infant formula to be fed ad libitum
Other: Experimental Hydrolyzed infant formula
Experimental hydrolyzed infant formula to be fed ad libitum


Ages Eligible for Study:   up to 180 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01573871

United States, Indiana
Northpoint Pediatrics
Indianapolis, Indiana, United States, 46038
United States, Ohio
Metro-Health Medical Center
Cleveland, Ohio, United States, 44109
Ohio Pediatric Research Association
Huber Heights, Ohio, United States, 45424
Sponsors and Collaborators
Abbott Nutrition
Study Chair: Marlene Borschel, PhD Abbott Nutrition
  More Information

Responsible Party: Abbott Nutrition Identifier: NCT01573871     History of Changes
Other Study ID Numbers: AK94
Study First Received: April 6, 2012
Last Updated: February 14, 2013 processed this record on September 21, 2017