Amino Acid Feed Children's Study

Nutricia

Status

Completed

Conditions

Milk Hypersensitivity

Treatments

Dietary Supplement: Amino Acid Feed

Study type

Interventional

Funder types

Industry

Identifiers

NCT02569840

NJ002

Details and patient eligibility

About

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.

Full description

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.

Enrollment

30 patients

Sex

All

Ages

1 to 10 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female
Age 1-10 years
Currently using or requiring an amino acid based feed
Expected to receive at least 30% of their energy intake from the study product
Written informed consent from parents / carer

Exclusion criteria

Parenteral nutrition contributing more than 70% of total energy intake
Children with major hepatic or renal dysfunction
Participation in other studies within 2 weeks prior to entry of this study
Investigator concern around willingness/ability of parent/carer to comply with protocol requirements