ESj- Powder Complete T&A Study

Anaiah Healthcare

Status: Unknown

Conditions: Child Malnutrition; Child Nutrition Disorders

Treatments: Other: EnergieShake® Junior Powder Complete

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04488718

ESj-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

EnergieShake® Junior Powder Complete (test)

Experimental group

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).

Treatment:

Other: EnergieShake® Junior Powder Complete