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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 : December 9, 2020
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

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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, DB 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 ]
    The primary endpoint is attained growth (i.e. incremental gains in weight) over the study period. Length and head circumference measures will also be collected and analysed. Both the growth velocities of the group as a whole (cross-sectional group data) and individuals (longitudinal individual data) will be reviewed and analysed. In assessing group data, comparisons of increments per unit of time will be made. Due to the varying ages of the subjects recruited to the study, growth measures will be concerted to z-scores using an appropriate reference population to allow a meaningful comparison of the ability of the formulas to promote growth. In assessing the growth of individual infants, data will be plotted on National Centre for Health Statistics (NCHS) growth charts and assessed qualitatively.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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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

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Sponsors and Collaborators
Nutricia North America
Nutricia Liverpool
Danone Institute International
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Study Director: Barbara Mourmans Study Mgr Nutricia Research - Centre for Specialised Nutrition
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Nutricia North America Identifier: NCT00664768    
Other Study ID Numbers: CT0131
First Posted: April 23, 2008    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: December 2020
Keywords provided by Nutricia North America:
Cow Milk Allergy
Stool microflora
Stool characteristics
Additional relevant MeSH terms:
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Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate