Child Malnutrition, Child Nutrition Disorders
Conditions
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.
Interventions
OTHEREnergieShake® Junior Powder Complete
Oral Nutritional Supplement
Sponsors
Brighton and Sussex University Hospitals NHS Trust
Great Ormond Street Hospital for Children NHS Foundation Trust
The Leeds Teaching Hospitals NHS Trust
Anaiah Healthcare Pvt Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United Kingdom
Contacts
Primary ContactElsa Brando
Outcome results
None listed