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Product acceptability data from 15 participants are required in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) and the Health Service Executive (HSE) submission for Ireland for product registration.
To evaluate the acceptability (including gastrointestinal tolerance and compliance) of an adult tube-feed formula with ingredients derived from food for the dietary management of participants who require a tube feed. .
The acceptability data from 15 participants will be collected in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) and the Health Service
Executive (HSE) for Ireland. Participants will be provided with one month supply of tube feed and will be asked to complete a daily diary and short questionnaire to record information allowing assessment of the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients well established on tube feeds will act as their own control | Other | Patients will switch from current to new tube feed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compleat | Dietary Supplement | Patients well established and stable on a standard enteral tube feed with food derived ingredients will act as their own controls and make a product switch |
| Measure | Description | Time Frame |
|---|---|---|
| Daily record via participant diary | Daily Gastrointestinal diary as questionnaire, increase, decrease or no change | 7 days |
| Formula intake diary | mL per day | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tanita Flood | Royal Hospital for Neuro-disability | Principal Investigator |
| Martha Van der Linde | Community Paediatric Dietitian Worcestershire, Hastings UK | Principal Investigator |
| Minal Patel | Barts and London Hospital Trust London UK | Principal Investigator |
| Adrian Gilson | Newham General Hospital London UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanita Flood | London | United Kingdom |
Will upload the data as it becomes available
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