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.

Autor: Roberts AEL; Swansea University Medical School, Swansea University, Swansea, SA2 8PP, Wales., Xanthe C; All Wales Adult Cystic Fibrosis Centre, Llandough Hospital, Penarth, CF62 2XX, Wales., Hopkins AL; All Wales Adult Cystic Fibrosis Centre, Llandough Hospital, Penarth, CF62 2XX, Wales., Bodger O; Swansea University Medical School, Swansea University, Swansea, SA2 8PP, Wales., Lewis P; Swansea University Medical School, Swansea University, Swansea, SA2 8PP, Wales., Mahenthiralingam E; Microbiomes, Microbes and Informatics group, Organisms and Environment Division, Cardiff School of Biosciences, Cardiff University, Cardiff, CF10 3AX, Wales., Duckers J; All Wales Adult Cystic Fibrosis Centre, Llandough Hospital, Penarth, CF62 2XX, Wales., Jenkins RE; Swansea University Medical School, Swansea University, Swansea, SA2 8PP, Wales. r.e.jenkins@swansea.ac.uk.
Jazyk: angličtina
Zdroj: Pilot and feasibility studies [Pilot Feasibility Stud] 2022 Sep 24; Vol. 8 (1), pp. 216. Date of Electronic Publication: 2022 Sep 24.
DOI: 10.1186/s40814-022-01175-0
Abstrakt: 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).
(© 2022. The Author(s).)
Databáze: MEDLINE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje