Dysphagia Signs and Symptoms
Conditions
Interventions
After enrollment into the study, participants remain on their usual mode of care (current powdered thickener for 7 days). During this time, the subject and/or their carer(s) will record tolerance and
Sponsors
Trisco Foods Pty Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years old and above 2. Already taking adequate amounts of thickened fluids as determined by the Speech and Language Therapist 3. Currently using a xanthan gum-based thickener that has been Advisory Committee on Borderline Substances (ACBS) approved 4. Expected to require thickened fluids for at least 4 more weeks from the point of recruitment 5. Already using xanthan gum thickener at a prescribed identified IDDSI level with no reported gastrointestinal difficulties 6. Able to give written consent or witnessed verbal consent if unable to write 7. Mild acquired communication difficulties who understand 3+ information-carrying words as determined by the Consent Support Tool CST 8. Participants with the cognitive ability to engage meaningfully in conversation and who can access and retain the study information and consent
Exclusion criteria
Exclusion criteria: 1. Not requiring thickened fluids. Specifically, who have not been prescribed thickened fluids by a qualified health practitioner after an oropharyngeal dysphagia diagnosis for acute or chronic swallowing difficulties 2. Requiring enteral tube feeding or parenteral nutrition, including patients who require top-up enteral feeding alongside the oral intake 3. Medical or dietary contraindications to any of the ingredients of PTI 4. The high (>85%) fibre content in xanthan gum may cause gastrointestinal difficulties. Therefore, participants that are currently using starch-based thickeners that do not contain fibre will be excluded 5. To avoid potentially adverse effects, participants with inflammatory bowel disease or previous bowel resection will be excluded due to the high (greater than 85%) fibre content of xanthan gum which can cause gastrointestinal irritation 6. Enrolled in any other studies concomitantly or within a month prior to entry into this study 7. The investigator has concerns regarding the ability or willingness of the patient and/or care provider to comply with protocol requirements 8. Currently using a pre-thickened beverage or have used PTI already 9. Using a powdered thickener that is not Advisory Committee on Borderline Substances (ACBS) approved 10. Significant cognitive difficulties 11. Acquired communication difficulty will be excluded if they present with significant visual and /or hearing difficulties, and have less than 3 keyword understanding, as these difficulties will have an impact on the completion of the survey
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Gastrointestinal tolerance of the liquid thickener measured using a non-validated gastrointestinal symptoms questionnaire daily for 14 days 2. Palatability of the liquid thickener measured using a non-validated palatability questionnaire on the last day of the intervention on day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Compliance and ease of use of liquid thickener as compared to the current mode of care (powdered thickener) measured using a non-validated fluid intake questionnaire daily | — |
Countries
England, United Kingdom
Contacts
Public ContactSarah Birchall
Outcome results
None listed