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Amino Acid Feed Children's Study

NCT ID: NCT02569840

Last Updated: 2017-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-10-31

Brief Summary

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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

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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.

Conditions

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Milk Hypersensitivity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Amino Acid Feed

An amino acid based multi-nutrient powdered feed

Group Type OTHER

Amino Acid Feed

Intervention Type DIETARY_SUPPLEMENT

Each child will receive the amino acid based feed for a period of up to 4 weeks (28 days). The feed prescription will be determined on an individual basis by the Dietitian responsible for the child's nutritional management. The child will take the feed orally or via a pre-existing naso-gastric, gastrostomy or jejunostomy tube.

Interventions

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Amino Acid Feed

Each child will receive the amino acid based feed for a period of up to 4 weeks (28 days). The feed prescription will be determined on an individual basis by the Dietitian responsible for the child's nutritional management. The child will take the feed orally or via a pre-existing naso-gastric, gastrostomy or jejunostomy tube.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nutricia UK Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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NJ002

Identifier Type: -

Identifier Source: org_study_id