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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

Owen Bodger Orcid Logo, Aled Roberts, Cendl Xanthe, Alison L. Hopkins, Owen Bodger, Paul Lewis, Eshwar Mahenthiralingam, Jamie Duckers, Rowena Jenkins Orcid Logo

Pilot and Feasibility Studies, Volume: 8, Issue: 1, Start page: 216

Swansea University Authors: Owen Bodger Orcid Logo, Aled Roberts, Rowena Jenkins Orcid Logo

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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...

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Published in: Pilot and Feasibility Studies
ISSN: 2055-5784
Published: Springer Science and Business Media LLC 2022
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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 (&#xB1; 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. 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spelling 2022-10-12T12:05:57.0394701 v2 61350 2022-09-26 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 8096440ab42b60a86e6aba678fe2695a 0000-0002-4022-9964 Owen Bodger Owen Bodger true false 2734a184ebdeb828c9403c77b7938de0 Aled Roberts Aled Roberts true false caf58cd775a27bf8b9ee340079a29cc0 0000-0001-6664-6099 Rowena Jenkins Rowena Jenkins true false 2022-09-26 HDAT 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) Journal Article Pilot and Feasibility Studies 8 1 216 Springer Science and Business Media LLC 2055-5784 Study Protocol, Cystic fibrosis, Respiratory infections, Infection control, Microbiology, Therapeutics 24 9 2022 2022-09-24 10.1186/s40814-022-01175-0 COLLEGE NANME Health Data Science COLLEGE CODE HDAT Swansea University External research funder(s) paid the OA fee (includes OA grants disbursed by the Library) The Waterloo Foundation Grant: JMR1082 The Hodge Foundation Grant: HMR1075 2022-10-12T12:05:57.0394701 2022-09-26T17:02:57.5414429 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Owen Bodger 0000-0002-4022-9964 1 Aled Roberts 2 Cendl Xanthe 3 Alison L. Hopkins 4 Owen Bodger 5 Paul Lewis 6 Eshwar Mahenthiralingam 7 Jamie Duckers 8 Rowena Jenkins 0000-0001-6664-6099 9 61350__25233__0e583c79c0524452b9a091e203c48b6c.pdf 40814_2022_Article_1175.pdf 2022-09-26T17:02:57.5411904 Output 1273810 application/pdf Version of Record true © 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. true eng http://creativecommons.org/licenses/by/4.0/
title 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
spellingShingle 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
Owen Bodger
Aled Roberts
Rowena Jenkins
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
author_id_str_mv 8096440ab42b60a86e6aba678fe2695a
2734a184ebdeb828c9403c77b7938de0
caf58cd775a27bf8b9ee340079a29cc0
author_id_fullname_str_mv 8096440ab42b60a86e6aba678fe2695a_***_Owen Bodger
2734a184ebdeb828c9403c77b7938de0_***_Aled Roberts
caf58cd775a27bf8b9ee340079a29cc0_***_Rowena Jenkins
author Owen Bodger
Aled Roberts
Rowena Jenkins
author2 Owen Bodger
Aled Roberts
Cendl Xanthe
Alison L. Hopkins
Owen Bodger
Paul Lewis
Eshwar Mahenthiralingam
Jamie Duckers
Rowena Jenkins
format Journal article
container_title Pilot and Feasibility Studies
container_volume 8
container_issue 1
container_start_page 216
publishDate 2022
institution Swansea University
issn 2055-5784
doi_str_mv 10.1186/s40814-022-01175-0
publisher Springer Science and Business Media LLC
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
document_store_str 1
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description 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)
published_date 2022-09-24T04:15:21Z
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