Manuka Honey Sinus Rinse Study

Not Applicable

Completed

• Conditions: Cystic Fibrosis; Infection, Bacterial
• Interventions: Device: Standard sinus rinse; Device: Manuka honey sinus rinse

• Registration Number: NCT04589897
• Lead Sponsor: Swansea University

Brief Summary

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

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 Timeline

• Study Start: 2019-01-07
• Study First Submitted: 2020-09-24
• Study First Submitted QC: 2020-10-15
• Study First Posted: 2020-10-19
• Status Verified: 2021-10
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Last Update Submitted: 2022-09-20
• Last Update Posted: 2022-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard	Standard sinus rinse	Standard sinus rinse
Experimental	Manuka honey sinus rinse	Manuka honey sinus rinse

Primary Outcome Measures

Name	Time	Method
Change in Sino-Nasal Outcome Test 22 (SNOT- 22) Score	Baseline and day 30 (+-7 days)	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

Secondary Outcome Measures

Name	Time	Method
Bacterial type and number	Baseline and day 30 (+-7 days)	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
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score	Baseline and day 30 (+-7 days)	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

Trial Locations

Locations (1)

All Wales Adult Cystic Fibrosis Center, University Hospital Llandough; 🇬🇧 Cardiff, United Kingdom