Milk Hypersensitivity Clinical Trial
Official title:
An Evaluation of the Tolerance and Acceptability of Neocate Junior an Amino Acid Based Formula for Children
This study of the tolerance and acceptability of an amino acid based feed will assess gastrointestinal (GI) tolerance, product intake and acceptability in relation to taste, smell, texture in 20 patients between 1-10 years currently using or requiring an amino acid based feed for the dietary management of Cows' Milk Allergy and food-allergy-associated conditions, over 4 weeks.
Dietary management of Cows' Milk Allergy (CMA) involves avoiding cow's milk protein in the
diet, whilst ensuring that an adequate nutritional intake is achieved with suitable
alternative foods or prescribable feeds. A number of studies and clinical insights indicate
that CMA is persisting longer than infancy, into later childhood and becoming more complex.
If a child has CMA, eliminating the offending allergens whilst maintaining an intake of food
that meets their nutritional requirements for growth and development is challenging due to
the significant nutritional contribution these foods make to a child's diet, particularly
milk and dairy products. This supports the need for alternatives to cow's milk to be
available for children >1year of age to help meet their nutritional needs. Aminoacid based
feeds are already widely used in clinical practice to meet this need. A new nutritionally
complete amino acid based powdered feed for the dietary management of CMA, or other
conditions where an amino acid based is recommended, in children aged 1-10yrs old, has been
developed.
This study is to support the use of this new amino acid based feed in clinical practice. The
study will evaluate the tolerance and acceptability of the amino acid based powdered feed in
20 children aged 1-10yrs of age receiving or requiring an amino acid based feed for the
dietary management of CMA and food allergy associated conditions, over 4 weeks. The primary
outcome will be gastrointestinal tolerance, with secondary outcomes of compliance,
acceptability, nutrient intake and anthropometry.
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