Manuka Honey Sinus Rinse Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-07

Study Completion Date

2021-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cystic Fibrosis Infection, Bacterial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental

Manuka honey sinus rinse

Group Type EXPERIMENTAL

Manuka honey sinus rinse

Intervention Type DEVICE

Will follow a modified NHS nasal rinse protocol with the addition of manuka honey

Standard

Standard sinus rinse

Group Type ACTIVE_COMPARATOR

Standard sinus rinse

Intervention Type DEVICE

will follow the standard NHS nasal rinse protocol

Interventions

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Manuka honey sinus rinse

Will follow a modified NHS nasal rinse protocol with the addition of manuka honey

Intervention Type DEVICE

Standard sinus rinse

will follow the standard NHS nasal rinse protocol

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No