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Tolerance and Acceptability of a gum based thickener.
To evaluate the tolerance and acceptability of AYMES MADRID, in patients that may require modified consistency fluids. Measuring GI tolerance, compliance, convenience and preference.
To obtain data to support an ACBS submissions for AYMES MADRID (to allow for prescription in the community at NHS expense).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Patients with dysphagia requiring Stage 1, 2 or 3 thickened fluids as determined by Speech and Language Therapist and who are expected to require provision of Stage 1, 2 or 3 thickened fluids for at least 2 further weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AYMES MADRID | Other | AYMES MADRID is a gum-based commercial thickener, that can be utilised to modify fluid consistencies to Stage 1, 2 or 3 (as per the National Descriptors for Texture Modification) to enhance the safety of fluids in those with dysphagia. |
| Measure | Description | Time Frame |
|---|---|---|
| GI side effects when using AYMES MADRID | Recording of absence/presence of any nausea, vomiting, abdominal pain, bloating / flatulence, when using AYMES MADRID as assessed by presence / absence of side effect compared to baseline period. | 9 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance with prescription of AYMES MADRID | Recording of amount of AYMES PARIS consumed by subjects compared to amount prescribed. Good compliance = >80% of prescribed being consumed. Same data collected for baseline product and compared with that of AYMES MADRID | 9 |
| Bowel habits of subjects when using AYMES MADRID - frequency |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AYMES International Ltd. | Haywards Heath | RH16 9PL | United Kingdom |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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Recording of bowel habits whilst subjects consuming AYMES MADRID, as assessed by frequency of bowel movements (number of stools per day) and compared to same data recorded during baseline period. |
| 9 days |
| Bowel habits of subjects when using AYMES MADRID - stool consistency | Recording of bowel habits whilst subjects consuming AYMES MADRID, as assessed by consistency of stools (assessed by Bristol Stool Chart) and compared to same data recorded during baseline period | 9 days |
| D010038 | Otorhinolaryngologic Diseases |