The Big Sip - Can we improve thickened fluids for people with swallowing problems
| ISRCTN | ISRCTN14298840 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14298840 |
| IRAS number | 314590 |
| Secondary identifying numbers | STH22185, IRAS 314590, CPMS 52295 |
- Submission date
- 13/12/2022
- Registration date
- 22/12/2022
- Last edited
- 07/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
The use of thickeners to thicken drinks and fluids in the routine care of patients with swallowing difficulties is a well-known practice that helps patients maintain hydration orally. Over the last decade, xanthan gum thickeners have grown in use as an alternative to starch-based thickeners. Precise ThickN INSTANT (PTI) is a novel product that delivers xanthan gum in a liquid form instead of a powder. The primary research objective of this study is to evaluate gastrointestinal tolerance, compliance, and preferences of participants with oropharyngeal dysphagia (OD) who are currently using a powder-based thickener when switched to PTI. The secondary research objectives of this study are to evaluate the acceptability of a new liquid thickener compared with the standard powder-based thickener that is the predominant product in use in England in the treatment of people with swallowing difficulties. This study aims to provide the required gastrointestinal tolerance, acceptability, compliance, and preference data for the Advisory Committee on Borderline Substances (ACBS).
Who can participate?
Adults who have been prescribed thickened fluids for clinical management
What does the study involve?
The study involves the oral administration of a liquid thickener food supplement and the subsequent evaluation of gastrointestinal tolerance and palatability of the thickener. Moreover, compliance and ease of use of the liquid thickener treatment as compared to the current mode of care (powdered thickener) will be evaluated.
What are the possible benefits and risks of participating?
The benefits of participating are that participants will be exposed to a new thickener which may be more palatable and offer more appealing thickened beverage options resulting in greater oral hydration compliance. Risks to participating are adverse reactions such as bloating, distention, diarrhea and or intolerance to the treatment thickening option.
Where is the study run from?
Sheffield Teaching Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
August 2021 to June 2023
Who is funding the study?
Precise Health, a division of Trisco Foods Pty Ltd (Australia)
Who is the main contact?
Sarah Birchall, sarah.birchall4@nhs.net (UK)
Contact information
Principal Investigator
Sheffield Teaching Hospitals NHS Foundation Trust
Head Office
8 Beech Hill Road
Sheffield
S10 2SB
United Kingdom
 ORCID ID |
0000-0001-7108-8386 |
|---|---|
| Phone | +44 (0)114 2712676 |
| sue.pownall2@nhs.net |
Scientific
Sheffield Teaching Hospitals NHS Foundation Trust
Head Office
8 Beech Hill Road
Sheffield
S10 2SB
United Kingdom
| ORCID ID |
0000-0003-1410-185X |
|---|---|
| Phone | +44 (0)114 2712676 |
| natascha.ullrich@nhs.net |
Public
Sheffield Teaching Hospitals NHS Foundation Trust
Head Office
8 Beech Hill Road
Sheffield
S10 2SB
United Kingdom
| ORCID ID |
0000-0002-6589-0716 |
|---|---|
| Phone | +44 (0)114 271 1658 |
| sarah.birchall4@nhs.net |
Study information
| Study design | Prospective single-arm intervention trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | The Big Sip. Can we improve thickened fluids for people with swallowing problems: an investigation into the gastrointestinal tolerance, acceptability, compliance and patient preference to Precise ThickN INSTANT thickener |
| Study acronym | The Big Sip |
| Study objectives | Evaluation of gastrointestinal tolerance and palatability of liquid thickener in the clinical management of oropharyngeal dysphagia patients for whom thickened fluids have been prescribed |
| Ethics approval(s) |
Approved 13/09/2022, London - Camberwell St Giles Research Ethics Committee (Ground Floor, Temple Quay House, 2 The Square, Bristol, BS1 6PN, United Kingdom; +44(0)2071048138; camberwellstgiles.rec@hra.nhs.uk), ref: 22/LO/0471 |
| Health condition(s) or problem(s) studied | Dysphagia |
| Intervention | 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 compliance data in the study diaries. The palatability of the participants’ current powdered thickener will be evaluated with a 6-question survey using an end-anchored 10-point hedonic scale. Enrolled participants will be switched from their current thickener to having all their beverages thickened with the treatment (liquid thickener). There will be a 5-day washout period to clear the gastrointestinal (GI) tract and ensure any GI issues are related to the specific treatment. During this time, the subject and/or their carer(s) will continue to record tolerance and compliance data in the study diaries. For the subsequent 14 days, enrolled participants will be served all their liquids thickened with the treatment. During this phase, daily questionnaires will be kept that continue to monitor all the indicators of gastrointestinal tolerance and compliance. On the last day of the intervention, the palatability of the treatment will be assessed with the same questionnaire used to assess the palatability of the participants’ baseline thickener during the phase I baseline period. |
| Intervention type | Supplement |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 30/08/2021 |
| Completion date | 30/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 29 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 25/11/2022 |
| Date of final enrolment | 31/05/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Glossop Road
Sheffield
S10 2JF
United Kingdom
York
YO31 8HE
United Kingdom
Sponsor information
Industry
54 Ron Boyle Crescent
Carole Park
4300
Australia
| Phone | +61737185800 |
|---|---|
| brenda@triscofoods.com | |
| Website | https://precisethickn.com.au/ |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Current publication and dissemination plan as of 04/08/2023: Planned publication in a scientific journal and conference poster due to small sample size. _____ Previous publication and dissemination plan: Planned publication in a conference poster due to small sample size |
| IPD sharing plan | The sponsor will not be sharing participant-level data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Other unpublished results | 04/08/2023 | No | No |
Additional files
Editorial Notes
07/08/2023: The IPD sharing plan has been added.
04/08/2023: The following changes have been made:
1. The intention to publish date has been changed from 11/07/2023 to 30/06/2024.
2. The publication and dissemination plan has been changed.
3. An unpublished results file has been uploaded.
16/06/2023: The total final enrolment was added.
05/04/2023: The following changes were made to the trial record:
1. The recruitment start date was changed from 04/12/2022 to 25/11/2022.
2. The recruitment end date was changed from 30/03/2023 to 31/05/2023.
3. The overall end date was changed from 24/04/2023 to 30/06/2023.
4. The intention to publish date was changed from 24/04/2024 to 11/07/2023.
5. The plain English summary was updated to reflect these changes.
16/01/2023: Internal review.
21/12/2022: Trial's existence confirmed by HRA and Health and Care Research Wales (HCRW).
