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| ID | Type | Description | Link |
|---|---|---|---|
| IRAS ID 341165 | Other Identifier | Yorkshire & The Humber - South Yorkshire Research Ethics Committee |
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This is a single arm, prospective, single-centre study to evaluate the gastrointestinal tolerance and compliance over a 28-day period using a tube feed with food derived ingredients.
Acceptability (including gastrointestinal tolerance, compliance of a paediatric vegetarian tube feed with food derived ingredients. Gastrointestinal tolerance will data will be collected using a 4point Likert scale, daily record of tube feed volume intake.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children will act as their own control for the nutritional product | Experimental | Gastrointestinal tolerance and daily formula intake over 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paediatric tube feed | Dietary Supplement | 500ml tube feed to be provided daily over 28 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal tolerance and formula intake | Daily gastrointestinal tolerance measured using a 4 point Likert scale of none, mild, moderate, severe symptoms over days. | From enrolment to end of study over 28 days |
| Formula volume intake in mL | Formula intake measured daily in mLs over 28 days. | From enrolment to end of study over 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sharan BSc (hons), Nutrition and Dietetics | Contact | +447557170649 | sharan.saduera@uk.nestle.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr Graeme O'Connor, PHD | Great Ormond Street Hospital Nutrition and Dietetics Department | Principal Investigator |
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