ESj- Powder Complete T&A Study

Not Applicable

• Conditions: Child Malnutrition; Child Nutrition Disorders
• Interventions: Other: EnergieShake® Junior Powder Complete

• Registration Number: NCT04488718
• Lead Sponsor: Anaiah Healthcare Pvt Ltd

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.

Study Timeline

• Study First Submitted: 2020-07-20
• Study First Submitted QC: 2020-07-27
• Study First Posted: 2020-07-28
• Study Start: 2020-09-24
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-03
• Primary Completion: 2021-04-24
• Study Completion: 2021-05-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EnergieShake® Junior Powder Complete (test)	EnergieShake® Junior Powder Complete	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).

Primary Outcome Measures

Name	Time	Method
Acceptability & Tolerance: questionnaire	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
Gastrointestinal Tolerance	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.

Trial Locations

Locations (3)

Leeds Children's Hospital,; 🇬🇧 Leeds, United Kingdom

Great Ormond Street Hospital Foundation Trust; 🇬🇧 London, United Kingdom

Brighton & Sussex NHS Trust; 🇬🇧 Brighton, United Kingdom