The Big Sip - Can we improve thickened fluids for people with swallowing problems

Not Applicable

Completed

• Conditions: Dysphagia; Signs and Symptoms

• Registration Number: ISRCTN14298840
• Lead Sponsor: Trisco Foods Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-22
• Study Completion: 2023-06-30
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 29

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified