Amino Acid Feed Children's Study

Milk Hypersensitivity Clinical Trial

Official title:

An Evaluation of the Tolerance and Acceptability of Neocate Junior an Amino Acid Based Formula for Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02569840
• Other study ID #: NJ002
• Status: Completed
• Phase: N/A
• First received: June 10, 2015
• Last updated: October 30, 2017
• Start date: November 2015
• Est. completion date: October 2017

Study information

• Verified date: October 2017
• Source: Nutricia UK Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Milk Hypersensitivity

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nutricia UK Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastro intestinal tolerance questionnaire	Gastro-intestinal tolerance will be recorded at baseline and on days 1, 2, 3 and 7 of week 1 of the study. During weeks 2 and 3 tolerance will be recorded once at the end of each week on days 14 and 21. During week 4, tolerance will be recorded on days 26, 27 and 28. Tolerance will be recorded using a standardised gastro-intestinal tolerance questionnaire, to be completed by the parents/carer	4 weeks
Secondary	Compliance with feed prescription (amount prescribed versus consumed)	Compliance with feed prescription will be assessed daily throughout the study by recording how much feed was received, to be recorded by the parents/carer. The amount prescribed by the Dietitian will be recorded at the start of the study, and any changes to this prescription also noted	4 weeks
Secondary	Product acceptability questionnaire	Feed acceptability (ease of use) will be assessed at the end of week 4 by questionnaire completed by the parents/carer.	4 weeks
Secondary	Nutrient intake (energy, protein and micronutrients)	Nutrient intake, including the intake of all nutrition provided (including the study product, any parenteral feeding, other enteral tube feeding, foods, drinks etc) will be recorded at baseline and on Day 28 by the Dietitian using 24hour recall, and then in 3 day food diaries at baseline (Days 1, 2 and 3) and Week 4 (Days 26, 27 and 28) by the parent/carer. A dietary analysis program will be used to calculate total dietary intake	4 weeks
Secondary	Weight (kg)	For safety purposes, at baseline and at the end of week 4, body weight (kg) will be measured where possible using standard methods, to the nearest 0.1kg using a weighing scale without heavy clothing. Height will also be measured, wherever possible, using standard measures to the nearest 0.1cm. For children up to 2yrs of age, head circumference will be measured where possible, using standard methods to the nearest 0.1cm	4 weeks
Secondary	Height (cm)	For safety purposes, at baseline and at the end of week 4, body weight (kg) will be measured where possible using standard methods, to the nearest 0.1kg using a weighing scale without heavy clothing. Height will also be measured, wherever possible, using standard measures to the nearest 0.1cm. For children up to 2yrs of age, head circumference will be measured where possible, using standard methods to the nearest 0.1cm	4 weeks
Secondary	Head circumference (cm)	For safety purposes, at baseline and at the end of week 4, body weight (kg) will be measured where possible using standard methods, to the nearest 0.1kg using a weighing scale without heavy clothing. Height will also be measured, wherever possible, using standard measures to the nearest 0.1cm. For children up to 2yrs of age, head circumference will be measured where possible, using standard methods to the nearest 0.1cm	4 weeks
Secondary	Safety by Adverse Event reporting	All adverse events will be recorded, throughout the study.	4 weeks