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Enterally fed adults and children who are assessed by the dietitian as requiring an adult high-energy, fibre-containing enteral formula will be recruited. Data from 15 participants are required in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) for product registration.
To evaluate the acceptability (including gastrointestinal tolerance and compliance) of a high energy, adult enteral formula with food-derived ingredients.This is a single arm, prospective, multi-centre study to evaluate the gastrointestinal tolerance and compliance over a 14-day period with the new tube feed.
Participants or their caregivers will be provided with 14-day supply of the new 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 | These patients will switch from current to new tube feed to assess acceptability and tolerance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compleat 1.5 HP | Dietary Supplement | Patients well established and stable on an enteral tube feed. This group will act as their own controls and switched to the new tube feed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Daily patient diaries | Daily monitor of gastrointestinal tolerance using questionnaire on increase, decrease or no change | 14 days |
| Daily formula intake | mL per day | 14 days |
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Inclusion Criteria:
Patients requiring an enteral tube feed (taking > 60% of energy needs from their feeding tube) as part of their dietary management for disease related malnutrition
Exclusion Criteria:
Inability to comply with the study protocol, in the opinion of the investigator
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| Name | Affiliation | Role |
|---|---|---|
| Martha Van Der Linde | Community Paediatric Dietitian Worcestershire North Nutrition and Dietetic Hastings Way, Worcester. UK | Principal Investigator |
| Amy Carter | The Walton Centre NHS Foundation Trust, Liverpool UK | Principal Investigator |
| Sam Ogundere | Lewisham and Greenwich NHS Trust London UK | Principal Investigator |
| Adrian Gilson | Newham General Hospital London UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Martha Van Der Linde | Worcester | United Kingdom |
will upload the data as it becomes available
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