DUBLIN

• Research type

  Research Study

• Full title

  DUBLIN - Tolerance and Acceptability Study

• IRAS ID

  215517

• Contact name

  Roger Wertheim-Aymes

• Contact email

  raymes@aymes.com

• Sponsor organisation

  AYMES International Ltd

• Duration of Study in the UK

  0 years, 0 months, 14 days

• Research summary

  The study objectives are to assess the gastro-intestinal tolerance as well as the compliance of taking AYMES DUBLIN in people in the community requiring Stage 1, 2 or 3 thickened fluids to be able to obtain data to support an ACBS submission to allow prescription of AYMES DUBLIN.
  Those with oropharyngeal disorders may require fluids to be modified to a consistency that gives the patient the best control over the rate food and fluids pass through the pharynx - these consistencies are outlined as per the "National Descriptors for Texture Modification in Adults” (11) guidelines by The British Dietetic Association (BDA) and Royal College of Speech and Language Therapists.

  AYMES DUBLIN is a starch-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.

  Ideally 20 residents of UK-based care sites who require thickened fluids will be recruited to the study. They will be monitored daily whilst they continue with their current thickener for 3 days (baseline) and then will be changed to AYMES DUBLIN for 2 days (transitional) and 7 days (intervention). Each participant will therefore be on the study for 12 days.
  Therefore between days 4-12, participants will consume AYMES DUBLIN instead of their usual prescribed thickener whenever they are given fluids. This is therefore an observational study where patients act as their own controls.

  This study is being carried out by members of the AC Health and Nutrition team, which include Dietitians. The trial is sponsored by AYMES International Ltd.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  16/EE/0442

• Date of REC Opinion

  1 Mar 2017

• REC opinion

  Further Information Favourable Opinion