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A pilot study investigating the effects of a manuka honey sinus rinse compared to a standard sinus rinse on sino-nasal outcome test scores in cystic fibrosis patients
,
Aled Roberts,
Cendl Xanthe,
Alison L. Hopkins,
Owen Bodger,
Paul Lewis,
Eshwar Mahenthiralingam,
Jamie Duckers,
Rowena Jenkins
Pilot and Feasibility Studies, Volume: 8, Issue: 1, Start page: 216
Swansea University Authors:
Owen Bodger , Aled Roberts, Rowena Jenkins
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© The Author(s) 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence.
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DOI (Published version): 10.1186/s40814-022-01175-0
Abstract
Abstract: Background: People with cystic fibrosis (CF) are prone to bacterial respiratory infections; these are often antibiotic resistant, are difficult to treat, and impact on the quality of life and lung function. The upper respiratory tract can act as a reservoir for these pathogens, and as part...
| Published in: | Pilot and Feasibility Studies |
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| ISSN: | 2055-5784 |
| Published: |
Springer Science and Business Media LLC
2022
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| Online Access: |
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| URI: | https://cronfa.swan.ac.uk/Record/cronfa61350 |
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| Abstract: |
Abstract: Background: People with cystic fibrosis (CF) are prone to bacterial respiratory infections; these are often antibiotic resistant, are difficult to treat, and impact on the quality of life and lung function. The upper respiratory tract can act as a reservoir for these pathogens, and as part of clinical care, sinus rinses are used to alleviate symptoms in the upper airway. We have developed a sinus rinse containing manuka honey, to identify whether it can help improve symptoms or reduce the bacterial load. Methods: We will undertake a randomised controlled trial where 30 adults with CF will be recruited and randomised to either the control or intervention group. Both groups will follow a sinus rinse protocol for 30 days (± 7 days); the control group will use the standard of care rinse, and the intervention group will use a manuka honey rinse. Both groups will provide samples at day 0 and day 30. The primary outcome measure will be a change in the 22-item Sino-Nasal Outcome Test (SNOT-22) score. Secondary outcomes will include changes to quality of life (questionnaire), bacterial load/community composition, and sputum viscosity. Discussion: This trial will look at the use of a manuka honey-infused sinus rinse solution on patients diagnosed with cystic fibrosis (CF) suffering with sinusitis; it will allow us to determine the efficacy of the manuka honey sinus rinse compared to standard rinse and will allow us to determine if molecular bacterial diversity analysis will provide in-depth information beyond the usual conventional microbiological. It will allow us to determine the feasibility of recruiting participants to this type of trial, allow us to check participant compliance with the protocol, and inform future studies. Trial registration: Approval was obtained from the Research Ethics Committee Wales REC7 reference 18/WA/0319. Results of this study will be published at international conferences and in peer-reviewed journals; they will also be presented to the relevant stakeholders and research networks. Trial registration number: ClinicalTrials.gov Identifier NCT04589897 (retrospectively registered) |
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| Keywords: |
Study Protocol, Cystic fibrosis, Respiratory infections, Infection control, Microbiology, Therapeutics |
| College: |
Faculty of Medicine, Health and Life Sciences |
| Funders: |
The Waterloo Foundation Grant: JMR1082 The Hodge Foundation Grant: HMR1075 |
| Issue: |
1 |
| Start Page: |
216 |