Back to resultsESj- Powder Complete T&A Study (ESj)
Primary Purpose
Child Nutrition Disorders, Child Malnutrition
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
EnergieShake® Junior Powder Complete
Sponsored by
About this trial
This is an interventional treatment trial for Child Nutrition Disorders
Eligibility Criteria
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
Sites / Locations
- Brighton & Sussex NHS TrustRecruiting
- Leeds Children's Hospital,
- Great Ormond Street Hospital Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EnergieShake® Junior Powder Complete (test)
Arm Description
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).
Outcomes
Primary Outcome Measures
Acceptability & Tolerance: questionnaire
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
Gastrointestinal Tolerance
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04488718
First Posted
July 20, 2020
Last Updated
February 1, 2021
Sponsor
Anaiah Healthcare Pvt Ltd
Collaborators
Brighton and Sussex University Hospitals NHS Trust, Great Ormond Street Hospital for Children NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT04488718
Brief Title
ESj- Powder Complete T&A Study
Acronym
ESj
Official Title
Evaluation of Tolerance and Acceptability of EnergieShake® Junior Powder Complete
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 24, 2020 (Actual)
Primary Completion Date
April 24, 2021 (Anticipated)
Study Completion Date
May 24, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anaiah Healthcare Pvt Ltd
Collaborators
Brighton and Sussex University Hospitals NHS Trust, Great Ormond Street Hospital for Children NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 will be submitted to the ACBS, who will consider it for reimbursement as a Food for Special Medical Purpose (FSMP) in the UK.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Nutrition Disorders, Child Malnutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EnergieShake® Junior Powder Complete (test)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
EnergieShake® Junior Powder Complete
Intervention Description
Oral Nutritional Supplement
Primary Outcome Measure Information:
Title
Acceptability & Tolerance: questionnaire
Description
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
Time Frame
7 days
Title
Gastrointestinal Tolerance
Description
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.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elsa Brando
Phone
+44 01843448538
Email
elsab@anaiahhealthcare.com
Facility Information:
Facility Name
Brighton & Sussex NHS Trust
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chris Smith
Facility Name
Leeds Children's Hospital,
City
Leeds
ZIP/Postal Code
LS2 9NS
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacqueline Lowdon
Facility Name
Great Ormond Street Hospital Foundation Trust
City
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Graeme O'Connor
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
no plan
Learn more about this trial
ESj- Powder Complete T&A Study
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