ESj- Powder Complete T&A Study (ESj)

February 1, 2021 updated by: Anaiah Healthcare Pvt Ltd

Evaluation of Tolerance and Acceptability of EnergieShake® Junior Powder Complete

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 will be submitted to the ACBS, who will consider it for reimbursement as a Food for Special Medical Purpose (FSMP) in the UK.

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Brighton, United Kingdom, BN2 5BE
        • Recruiting
        • Brighton & Sussex NHS Trust
        • Contact:
          • Chris Smith
      • Leeds, United Kingdom, LS2 9NS
        • Not yet recruiting
        • Leeds Children's Hospital,
        • Contact:
          • Jacqueline Lowdon
      • London, United Kingdom, WC1N 3JH
        • Recruiting
        • Great Ormond Street Hospital Foundation Trust
        • Contact:
          • Graeme O'Connor

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

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Other: EnergieShake® Junior Powder Complete
Oral Nutritional Supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability & Tolerance: questionnaire
Time Frame: 7 days
Acceptability of test product will be tested in children using a questionnaire with a liking scale (Liking Scale - 1-10 - 0 being dislike and 10 being like a lot) and compliance (intake/day versus prescribed dose) of the test product over a 7 day period and compared to acceptability when consuming their current oral nutritional supplement
7 days
Gastrointestinal Tolerance
Time Frame: 7 days
Gastrointestinal (GI) tolerance of test product will be determined in children using a questionnaire detailing daily bowel habits and symptoms that occur (new or worsening) while consuming the test product over a 7 day period and compared to GI tolerance when consuming their current oral nutritional supplement. This is established using a combination of the Bristol Stool Chart scoring (BSC - type 1 up to type 7) before and during the study along with number of bowel movements/day and stool consistency.
7 days

Collaborators and Investigators

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

Sponsor

Anaiah Healthcare Pvt Ltd

Collaborators

The Leeds Teaching Hospitals NHS Trust
Brighton and Sussex University Hospitals NHS Trust
Great Ormond Street Hospital for Children NHS Foundation Trust

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)

September 24, 2020

Primary Completion (Anticipated)

April 24, 2021

Study Completion (Anticipated)

May 24, 2021

Study Registration Dates

First Submitted

July 20, 2020

First Submitted That Met QC Criteria

July 27, 2020

First Posted (Actual)

July 28, 2020

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESj-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no plan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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