Status:

UNKNOWN

ESj- Powder Complete T&A Study

Lead Sponsor:

Anaiah Healthcare Pvt Ltd

Collaborating Sponsors:

Brighton and Sussex University Hospitals NHS Trust

Great Ormond Street Hospital for Children NHS Foundation Trust

Conditions:

Child Nutrition Disorders

Child Malnutrition

Eligibility:

All Genders

1-18 years

Phase:

NA

Brief Summary

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

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 ...

Eligibility Criteria

Inclusion

  • \>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

  • 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

Key Trial Info

Start Date :

September 24 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 24 2021

Estimated Enrollment :

18 Patients enrolled

Trial Details

Trial ID

NCT04488718

Start Date

September 24 2020

End Date

May 24 2021

Last Update

February 3 2021

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Brighton & Sussex NHS Trust

Brighton, United Kingdom, BN2 5BE

2

Leeds Children's Hospital,

Leeds, United Kingdom, LS2 9NS

3

Great Ormond Street Hospital Foundation Trust

London, United Kingdom, WC1N 3JH