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| Name | Class |
|---|---|
| Brighton and Sussex University Hospitals NHS Trust | OTHER |
| Great Ormond Street Hospital for Children NHS Foundation Trust | OTHER |
| The Leeds Teaching Hospitals NHS Trust | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EnergieShake® Junior Powder Complete (test) | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EnergieShake® Junior Powder Complete | Other | Oral Nutritional Supplement |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Participants requiring exclusive enteral tube feeding
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elsa Brando | Contact | +44 01843448538 | elsab@anaiahhealthcare.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brighton & Sussex NHS Trust | Recruiting | Brighton | BN2 5BE | United Kingdom |
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| ID | Term |
|---|---|
| D015362 | Child Nutrition Disorders |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Leeds Children's Hospital, | Not yet recruiting | Leeds | LS2 9NS | United Kingdom |
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| Great Ormond Street Hospital Foundation Trust | Recruiting | London | WC1N 3JH | United Kingdom |
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