PTIUK

• Research type

  Research Study

• Full title

  Investigation Into The Gastrointestinal Tolerance, Acceptability, Compliance And Patient Preference To Precise Thickn Instant Thickener

• IRAS ID

  314590

• Contact name

  Sue Pownall

• Contact email

  sue.pownall2@nhs.net

• Sponsor organisation

  TRISCO FOODS PTY LTD

• ISRCTN Number

  ISRCTN14298840

• Clinicaltrials.gov Identifier

  STH22185, STH22185

• Duration of Study in the UK

  0 years, 8 months, 28 days

• Research summary

  The aim of this study is to explore the use of Precise ThickN Instant PTI a liquid thickener with patients who have swallowing difficulties in England. Data will be collected on the gastrointestinal tolerance, acceptability, compliance, and preference of the product and compared with the prescribed thickening agent currently in use by the participant with swallowing difficulties.
  As patient acceptability is fundamental to the successful use of any product, investigation is needed to assess the acceptability of PTI as part of routine care in patients with oro-pharyngeal dysphagia (OD). The study is conducted for Advisory Committee on Borderline Substances ACBS.

  This is the first study of its kind in England, and recruitment of participants will seek to include patients in an acute hospital setting, sub-acute ward setting and care homes to contribute data to the existing research on PTI which thus far has had a focus on domiciliary settings. The time it takes for a drink to thicken with PTI is reported to be measurably faster compared to powder based thickened drinks, and this time saving property may reduce time demands on care staff in hospital and care settings. In addition, greater consistency of viscosity levels across drinks across time is more guaranteed due to product stability. This provides a greater safety aspect for patients with OD. Furthermore, exploring palatability will provide further evidence about acceptability of PTI, giving professionals and patients with OD a greater range of thickening agents to consider. Choice and communication is a valuable tool in the management of swallowing problems. The study is led by Speech and Language Therapists; therefore, the inclusion of participants who have aphasia post stroke in addition to OD is sought. This substantial group of patients is frequently excluded from participation in stroke research due to a language barrier.

• REC name

  London - Camberwell St Giles Research Ethics Committee

• REC reference

  22/LO/0471

• Date of REC Opinion

  13 Sep 2022

• REC opinion

  Further Information Favourable Opinion