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| ID | Type | Description | Link |
|---|---|---|---|
| IRAS ID 341165 | Other Identifier | West of Scotland REC 5 West of Scotland Research Ethics Service, Ward 11, Dykebar Hospital Grahamston Road PAISLEY PA2 |
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This is a prospective acceptability study to evaluate the gastrointestinal tolerance and compliance of a bolus tube feed over a 28 -day period for up to 50 participants.
The enteral bolus formula is for the dietary management of patients with short bowel syndrome; intractable malabsorption; preoperative preparation of undernourished patients; inflammatory bowel disease; total gastrectomy; dysphagia; bowel fistulae; feeding intolerances, developmental disabilities, and disease related malnutrition.
The study will collect data in 50 children and adults over a period of 28 days. Gastrointestinal tolerance will be collected over 7 days and formula intake will be over 28 days. A patient satisfaction questionnaire will be completed at the end of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acceptability and Tolerance Study of bolus tube feed with food blends | Other | Arm one will act as their own controls |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tube feed | Dietary Supplement | Dose intake and duration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure of Gastrointestinal tolerance | Severity of symptoms such as reflux, vomiting, constipation, diarrhoea as a four-point likert scale (none, mild, moderate, severe). | 7 days |
| Daily record of formula intake. | Measure of formula intake in mL. | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sharan Saduera, BSc (Hons) Dietetics | Contact | +447557170649 | sharan.saduera@uk.nestle.com | |
| Sarah Durnan, PHD, BSc Nutrition Dietetics | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Medical Hospital Nutrition and Dietetics | Not yet recruiting | Nottingham | NG7 2UH | United Kingdom |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004750 | Enteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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| Dietetic Team 1st floor Kings Court 1, Charles Hastings Way, | Recruiting | Worcester | WR5 1JR | United Kingdom |
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