A Growth and Hypoallergenicity Study of a New Formula for Infants With Cow Milk Allergy (CMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00664768
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : March 6, 2015
Nutricia Liverpool
Danone Institute International
Information provided by (Responsible Party):
Nutricia North America

Brief Summary:

This study involves the use of 2 different Neocate formulas: a control formula called Neocate Infant and a test Neocate formula. These kinds of formulas are for use in children from birth to 8 months of age with Cow Milk Allergy (CMA), other food allergies, and other gastrointestinal disorders. The purpose of this study is to compare the control and test Neocate formulas for safety, tolerability, and effectiveness (in promoting growth) when used in subjects with CMA.

This study will also look at the test Neocate formula to see if it is hypoallergenic when used in subjects with CMA.

Condition or disease Intervention/treatment Phase
Cow Milk Allergy Dietary Supplement: Neocate Infant Dietary Supplement: new Neocate Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-Blind Controlled Study to Evaluate the Nutritional Safety (Growth) of an Amino Acid Based Formula With Prebiotics and Probiotics in Infants Diagnosed With Cow Milk Allergy, With or Without Other Food Allergies.
Study Start Date : March 2008
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: New Neocate
new Neocate
Dietary Supplement: new Neocate
minimum of 8 fl oz daily

Active Comparator: Neocate Infant
Neocate Infant formula
Dietary Supplement: Neocate Infant
minimum of 8 fl. oz daily

Primary Outcome Measures :
  1. The primary endpoint is attained growth (i.e. incremental gains in weight) over the study period. [ Time Frame: 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 8 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subjects aged from birth to 8 months old with documented allergy to cow milk protein are eligible to enter the study. Subjects with other IgE or non IgE mediated allergies to food in addition to milk protein (e.g. multiple food allergy or an eosinophilic disorder) are also eligible to enter the study. However all subjects must have a confirmed allergy to milk confirmed by one of the following criteria, within two months prior to the baseline visit:

    • Positive double-blind placebo controlled food challenge with cow milk
    • A confirmed history of acute severe reaction after isolated accidental ingestion with a positive test result for IgE antibody
    • Confirmed history of a reaction to cow milk protein with CM-specific IgE of >15kU/L for children over two years and > 5kU/L for children under two years.
    • Confirmed clinical history of a reaction to cow milk protein with a positive skin prick test with a resulting wheal diameter greater or equal to 3mm.
    • No confirmed clinical history of a reaction to cow milk protein subjects with a positive skin prick test with a resulting wheal diameter greater or equal to 8mm for children over 2 years and greater or equal to 6mm for children under 2 years.
    • For children with an Allergic Eosinophilic Gastroenteritis (AEG), documentation of eosinophilic infiltration and resolution of symptoms on a diet that restricted cow milk (and other foods) with reoccurrence after re-administration of cow milk.
  2. Written informed consent / ability to give informed consent.
  3. These subjects are expected to consume a minimum intake of test formula to ensure an average daily intake, which provides at least 50% of their daily energy requirements,

Exclusion Criteria:

All subjects

  1. Infants <5lb 8oz at birth
  2. Infants < 37 weeks gestation
  3. Infants with severe concurrent illness or major congenital malformations
  4. Suspected or documented systemic or congenital infections (e.g. human immunodeficiency virus)
  5. Unable to adhere to protocol instructions due to non compliance of parent or caregiver
  6. Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
  7. Participation in any other studies involving investigational products concomitantly or within twenty eight days prior to entry into the study
  8. An infant of any personnel connected with the study
  9. Infants whose parent/caregiver is younger than the legal age of consent
  10. For these subjects the dietary consumption of other sources of prebiotics or probiotics is prohibited two weeks prior to inclusion in the study and during the study period.
  11. These subjects must not have received systemic antibiotics in the previous two weeks prior to entry into the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00664768

United States, Arizona
Pendleton Pediatrics
Chandler, Arizona, United States, 85224
Visions Clinical Research - Tucson
Tucson, Arizona, United States, 85712
United States, Arkansas
Children's Investigational Research Program, LLC (CHIRP)
Bentonville, Arkansas, United States, 72712
United States, California
Children's Hospital, LA
Los Angeles, California, United States, 90027
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
Rosario B. Retino, MD, Inc
Ontario, California, United States, 91762
Choc Psf, Amc
Orange, California, United States, 92868
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
United States, Illinois
Alzein Pediatrics
Evergreen Park, Illinois, United States, 60805
United States, Louisiana
Regional Research Specialists, LLC
Shreveport, Louisiana, United States, 71106
United States, Missouri
Craig A. Spiegel, M.D.
Bridgeton, Missouri, United States, 63044
United States, Nebraska
Meridian Clinical Research, LLC
Omaha, Nebraska, United States, 68134
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021
United States, North Carolina
Asheboro Research Associates
Asheboro, North Carolina, United States, 27203
Duke University
Durham, North Carolina, United States, 27710
Pediatrics, PLLC
Holly Springs, North Carolina, United States, 27540
United States, Ohio
John Panuto, M.D.
Middleburg Heights, Ohio, United States, 44130
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Virginia
PI-Coor Clinical Research, LLC
Burke, Virginia, United States, 22015
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
Advanced Pediatrics
Vienna, Virginia, United States, 22180
Sponsors and Collaborators
Nutricia North America
Nutricia Liverpool
Danone Institute International
Study Director: Barbara Mourmans Senior Clinical Study Manager Nutricia Research - Centre for Specialised Nutrition P.O. Box 7005 - 6700 CA Wageningen - The Netherlands

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Nutricia North America Identifier: NCT00664768     History of Changes
Other Study ID Numbers: CT0131
First Posted: April 23, 2008    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: October 2012

Keywords provided by Nutricia North America:
Cow Milk Allergy
Stool microflora
Stool characteristics

Additional relevant MeSH terms:
Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate