Clinical trial NCT02569840: Amino Acid Feed Children's Study
Official title: An Evaluation of the Tolerance and Acceptability of Neocate Junior an Amino Acid Based Formula for Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Milk Hypersensitivity
Lead sponsor: Nutricia UK Ltd
Sponsor class: INDUSTRY
First posted: 2015-10-07
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Gastro intestinal tolerance questionnaire
timeFrame: 4 weeks
Secondary outcomes:
measure: Compliance with feed prescription (amount prescribed versus consumed)
timeFrame: 4 weeks
measure: Product acceptability questionnaire
timeFrame: 4 weeks
measure: Nutrient intake (energy, protein and micronutrients)
timeFrame: 4 weeks
measure: Weight (kg)
timeFrame: 4 weeks
measure: Height (cm)
timeFrame: 4 weeks
measure: Head circumference (cm)
timeFrame: 4 weeks
measure: Safety by Adverse Event reporting
timeFrame: 4 weeks
Other outcomes:
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