Amino acid feed children’s study NJ002
Research type
Research Study
Full title
An evaluation of the tolerance, and acceptability of an amino acid based feed for children
IRAS ID
183591
Contact name
Rebecca Stratton
Contact email
Sponsor organisation
Nutricia Ltd
Duration of Study in the UK
1 years, 10 months, 30 days
Research summary
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. Amino-acid based feeds are already widely used in clinical practice to meet this need.
Nutricia is a medical nutrition company, which already makes other amino acid based feeds for CMA, has developed 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.
This study is to support the use of this new amino acid based feed in clinical practice and to support an application to the Advisory Committee of Borderline Substances for the product to be available on NHS prescription.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.
Data will be collected using questionnaires, with no invasive measures. The feed is a Food for Special Medical Purposes and MHRA exempt.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
15/SC/0397
Date of REC Opinion
17 Aug 2015
REC opinion
Further Information Favourable Opinion