Amino Acid Feed Children's Study

October 30, 2017 updated by: Nutricia UK Ltd

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Amino Acid Feed
An amino acid based multi-nutrient powdered feed
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gastro intestinal tolerance questionnaire
Time Frame: 4 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Compliance with feed prescription (amount prescribed versus consumed)
Time Frame: 4 weeks
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
Product acceptability questionnaire
Time Frame: 4 weeks
Feed acceptability (ease of use) will be assessed at the end of week 4 by questionnaire completed by the parents/carer.
4 weeks
Nutrient intake (energy, protein and micronutrients)
Time Frame: 4 weeks
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
Weight (kg)
Time Frame: 4 weeks
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
Height (cm)
Time Frame: 4 weeks
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
Head circumference (cm)
Time Frame: 4 weeks
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
Safety by Adverse Event reporting
Time Frame: 4 weeks
All adverse events will be recorded, throughout the study.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nutricia UK Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 7, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NJ002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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