ESj- Powder Complete T&A Study

Child Malnutrition Clinical Trial

— ESj  

Official title:

Evaluation of Tolerance and Acceptability of EnergieShake® Junior Powder Complete

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04488718
• Other study ID #: ESj-01
• Status: Recruiting
• Phase: N/A
• Start date: September 24, 2020
• Est. completion date: May 24, 2021

Study information

• Verified date: February 2021
• Source: Anaiah Healthcare Pvt Ltd
• Contact: Elsa Brando
• Phone: +44 01843448538
• Email: elsab[@]anaiahhealthcare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: May 24, 2021
• Est. primary completion date: April 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Malnutrition
• Child Nutrition Disorders
• Malnutrition
• Nutrition Disorders

Intervention

Other:
• EnergieShake® Junior Powder Complete
Oral Nutritional Supplement

Locations

Country	Name	City	State
United Kingdom	Brighton & Sussex NHS Trust	Brighton
United Kingdom	Leeds Children's Hospital,	Leeds
United Kingdom	Great Ormond Street Hospital Foundation Trust	London

Sponsors (4)

Lead Sponsor	Collaborator
Anaiah Healthcare Pvt Ltd	Brighton and Sussex University Hospitals NHS Trust, Great Ormond Street Hospital for Children NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7 days
Primary	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.	7 days