A Growth and Hypoallergenicity Study of a New Formula for Infants With Cow Milk Allergy (CMA)
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|ClinicalTrials.gov Identifier: NCT00664768|
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : December 9, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
Experimental: 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
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT00664768
|Study Director:||Barbara Mourmans||Study Mgr Nutricia Research - Centre for Specialised Nutrition|