Manuka Honey Sinus Rinse Study

A Pilot Study Investigating the Effects of a Manuka Honey Sinus Rinse on Sino-nasal Outcome Test Scores in Cystic Fibrosis Patients

A trial investigating the effect of a sinus rinse in people with CF

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis; Infection, Bacterial
• Intervention / Treatment: Device: Manuka honey sinus rinse; Device: Standard sinus rinse

Detailed Description

People with with CF often have bacterial infection in their air ways. There is great interest in the different types of bacteria found within these infections.

This clinical trial looks at whether a novel sinus rinse device (that incorporates manuka honey) could help clear infection or reduce the amount and/or types of bacteria found within the upper airway. This study assesses the changes in the Sino-Nasal Outcome Test (SNOT-22) scores along with any changes in quality of life, before and after the use of a sinus rinse device for 30 days.

In addition to this, the amount and types of bacteria found in nasal swabs, the sinus rinse solution, and sputum samples, before and after using the sinus rinse device will be investigated. Sputum samples will also be monitored for changes in composition before and after using the sinus rinse.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cardiff, United Kingdom, CF62 2XX
    • All Wales Adult Cystic Fibrosis Center, University Hospital Llandough

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patient is willing and able to give informed consent.
• The patient must be ≥ 18 years.
• The patient must have an established diagnosis of CF (one or more of the following) Sweat chloride >60mEq/L Presence of two CF causing mutations.
• The patient must have chronic symptoms of rhinosinusitis according to the criteria of the European Position Paper on Rhinosinusitis (appendix A).
• The patient scores greater ≥ 7 on their SNOT-22 questionnaire.

Exclusion Criteria:

• The patient has ever tested positive for the bacteria Mycobacterium tuberculosis.
• The patient is currently using a nasal rinse protocol.
• The patient has undergone sinus surgery within 6 months.
• The patient suffers from nasal bleeding.
• The patient is currently undergoing systemic antibiotic therapy for infective exacerbation.
• The patient is using overnight oxygen via nasal cannula.
• The patient is participating in another clinical trial or has done so within the last 30 days.
• The patient has a known allergy to bee products.
• The patient has an objection to the use of bee products

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Manuka honey sinus rinse	Device: Manuka honey sinus rinse; Will follow a modified NHS nasal rinse protocol with the addition of manuka honey
Active Comparator: Standard; Standard sinus rinse	Device: Standard sinus rinse; will follow the standard NHS nasal rinse protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Sino-Nasal Outcome Test 22 (SNOT- 22) Score	Does the addition of manuka honey to the sinus rinse change the Sino Nasal Outcome Test (SNOT)-22 score of patients with cystic fibrosis? The SNOT-22 scale runs from 0 -110 and a higher score indicating worse symptoms	Baseline and day 30 (+-7 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score	Does the addition of manuka honey to a sinus rinse change the CFQ-R score in patients with cystic fibrosis? The scale runs from 1-100 and a higher score indicates a better outcome	Baseline and day 30 (+-7 days)
Bacterial type and number	Does the addition of manuka honey to a sinus rinse impact on the bacterial type/amount found in the nasal/paranasal cavities of patients with cystic fibrosis	Baseline and day 30 (+-7 days)

Collaborators and Investigators

• Sponsor: Swansea University
• Collaborators: University Hospital of Wales
• Investigators: Principal Investigator: Jamie Duckers, National Health Service, United Kingdom

Publications and helpful links

General Publications

• Roberts AEL, Xanthe C, Hopkins AL, Bodger O, Lewis P, Mahenthiralingam E, Duckers J, Jenkins RE. 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. Pilot Feasibility Stud. 2022 Sep 24;8(1):216. doi: 10.1186/s40814-022-01175-0.

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2019
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: September 24, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 20, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Bacterial Infections and Mycoses; Pancreatic Diseases; Fibrosis; Cystic Fibrosis; Bacterial Infections
• Other Study ID Numbers: JMR1075-100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data collected during the trial that underlie the results to be reported in an article after deidentification.
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: Anyone who wishes to access the data.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No