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Patients with short bowel intestinal failure are recommended to aim for a diet high in energy and protein. Some patients have difficulties in achieving recommended intakes and additional nutrition may be provided by oral nutritional supplements. There is very little research completed on which is the best oral nutritional supplement for patients. The aim of the study is to see the effect different oral nutritional supplements have on your stoma or fistula output and levels of hydration.
After written consent is obtained, patients will be asked to fast from 12.00am on day one. At 08.00am patients will be asked to pass urine and to empty their stoma bag. After this they will be asked to drink 200ml of the ONS which they have been randomised to test on day one over a 30 minute period. Urine and intestinal output will be collected into two separate containers over the next 6 hours. During this time the patient will not be permitted to eat or drink other fluids. After 6 hours the patient will be able to eat and drink normally. The urine and intestinal output will be weighed and then an aliquot will be stored in a -20oC freezer before being sent for analysis. Day two is a washout day when the patient will be able to eat and drink normally. Day three will be the same as day one but the patient will have the other ONS that they did not have on day one. No changes will be made to the patient's usual anti diarrhoeal and/or anti motility agents or parenteral support during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vital 1.5 | Experimental | 200ml orally over 30 minutes |
|
| Ensure Plus | Active Comparator | 200ml orally over 30 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vital 1.5 | Dietary Supplement | Oral nutritional supplement |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in faecal sodium | Change in faecal sodium | Day 1 and 3 |
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Inclusion Criteria:
Exclusion Criteria:
CReactive Protein >10 Albumin <30g/L Platelets >400
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| Name | Affiliation | Role |
|---|---|---|
| alison culkin, PhD | London Northwest Healthcare Trust | Principal Investigator |
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| ID | Term |
|---|---|
| D012778 | Short Bowel Syndrome |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C029401 | Ensure Plus |
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| Ensure Plus |
| Dietary Supplement |
Oral nutritional supplement |
|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |