AYMES International Ltd.
Haywards Heath, RH16 9PL, United Kingdom
NCT Number: NCT03834896
Tolerance and Acceptability of a gum based thickener.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Haywards Heath, RH16 9PL, United Kingdom
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 9 Days
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.
Time frame: 9
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
Time frame: 9 days
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.
Time frame: 9 days
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
Aymes International Limited
Industry
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