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A Growth and Hypoallergenicity Study of a New Formula for Infants With Cow Milk Allergy (CMA)
This study is currently recruiting participants.
Verified by Nutricia North America, April 2008
Sponsored by: Nutricia North America
Information provided by: Nutricia North America
ClinicalTrials.gov Identifier: NCT00664768
  Purpose

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 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 Intervention
Cow Milk Allergy
Dietary Supplement: Neocate Infant
Dietary Supplement: new Neocate

MedlinePlus related topics: Allergy Dietary Supplements Food Allergy
Drug Information available for: Amino acids, branched-chain
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Prospective, Randomized, Double-Blind Controlled Study to Evaluate the Nutritional Safety (Growth) and Hypoallergenicity of an Amino Acid Based Formula With Prebiotics and Probiotics in Infants Diagnosed With Cow Milk Allergy, With or Without Other Food Allergies.

Further study details as provided by Nutricia North America:

Primary Outcome Measures:
  • The primary endpoint is attained growth (i.e. incremental gains in weight) over the study period. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 109
Study Start Date: March 2008
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
New Neocate: Experimental
new Neocate
Dietary Supplement: new Neocate
minmum of 8 fl oz daily
Neocate Infant: Active Comparator Dietary Supplement: Neocate Infant
minimum of 8 fl. oz daily

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects aged from birth to 3 years 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.

    Subjects aged from birth up to 8 months of age;

  3. Suitable for inclusion into Phase I and II of the study.
  4. 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, during the seven-day, post challenge feeding period and the Phase II growth assessment.

    Subjects aged over 8 months to 3 years old

  5. Suitable for inclusion into Phase I only
  6. These subjects are expected to consume a minimum of 8 fl. oz per day of study formula during the seven-day, post-challenge feeding period

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

    Subjects aged from birth up to 8 months of age;

  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00664768

Locations
United States, California
Choc Psf, Amc Recruiting
Orange, California, United States, 92868
Contact: Elia Gonzales     714-633-6363        
United States, Georgia
Clinical Research Atlanta Recruiting
Stockbridge, Georgia, United States, 30281
Contact: Susan Frank     770-507-6867        
United States, North Carolina
Duke University Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Pamela Steele     919-732-2297        
United States, Pennsylvania
Childrens Hospital of Pittsburgh Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Elizabeth Hartigan     412-692-7885        
United States, Virginia
Huguenot Pediatrics Recruiting
Midlothian, Virginia, United States, 23113
Contact: Tammy Creasy     804-794-2299        
Advanced Pediatrics Recruiting
Vienna, Virginia, United States, 22180
Contact: Mary Margaret Thorne     703-938-5581        
Sponsors and Collaborators
Nutricia North America
  More Information

Responsible Party: Nutricia North America ( Steven Yannicelli, PhD, RD )
Study ID Numbers: CT0131
Study First Received: April 21, 2008
Last Updated: April 22, 2008
ClinicalTrials.gov Identifier: NCT00664768  
Health Authority: United States: Institutional Review Board

Keywords provided by Nutricia North America:
hypoallergenicity
Cow Milk Allergy
DBPCFC
Stool micorflora
Stool characteristics

Study placed in the following topic categories:
Food Hypersensitivity
Hypersensitivity
Milk Hypersensitivity
Hypersensitivity, Immediate

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009