ESj- Powder Complete T&A Study

NCT ID: NCT04488718

Last Updated: 2021-02-03

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-24

Study Completion Date

2021-05-24

Brief Summary

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The goal of this study is to gather data on the tolerance and acceptability of a new ONS (ESj-powder complete) in children currently taking ONS.

Detailed Description

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The goal of this study is to demonstrate the tolerance and acceptability of the test product when consumed by children who are currently prescribed (a similar) ONS. The data generated from this study will be submitted to the ACBS, who will consider it for reimbursement as a Food for Special Medical Purpose (FSMP) in the UK.

Conditions

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Child Nutrition Disorders Child Malnutrition

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EnergieShake® Junior Powder Complete (test)

EnergieShake® Junior Powder Complete will be consumed by children, as a supplement to normal diet, over a period of 7 day period to determine its acceptability (liking, compliance) and tolerance (gastro-intestinal tolerance). The dose will be the same as currently consumed product (all children recruited to the study will be consuming an oral nutritional supplement).

Group Type EXPERIMENTAL

EnergieShake® Junior Powder Complete

Intervention Type OTHER

Oral Nutritional Supplement

Interventions

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EnergieShake® Junior Powder Complete

Oral Nutritional Supplement

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* \>1-18 years of age
* Children currently prescribed and consuming Oral Nutritional Supplements (ONS)
* Willingness to take part in the study, and consent to the study protocol signed by parent/guardian or older child (when appropriate)

Exclusion Criteria

Participants requiring exclusive enteral tube feeding

* Participants on parenteral nutrition
* Participants with cow's milk or soy allergy or lactose intolerance
* Participants with galactosaemia
* Participants with a chronic renal or liver disease
* Participants who are acutely unwell
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brighton and Sussex University Hospitals NHS Trust

OTHER

Sponsor Role collaborator

Great Ormond Street Hospital for Children NHS Foundation Trust

OTHER

Sponsor Role collaborator

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role collaborator

Anaiah Healthcare Pvt Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Brighton & Sussex NHS Trust

Brighton, , United Kingdom

Site Status RECRUITING

Leeds Children's Hospital,

Leeds, , United Kingdom

Site Status NOT_YET_RECRUITING

Great Ormond Street Hospital Foundation Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Elsa Brando

Role: CONTACT

+44 01843448538

Facility Contacts

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Chris Smith

Role: primary

Jacqueline Lowdon

Role: primary

Graeme O'Connor

Role: primary

Other Identifiers

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ESj-01

Identifier Type: -

Identifier Source: org_study_id

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