Manuka Honey Sinus Rinse Study

Swansea University

Status: Completed

Conditions: Cystic Fibrosis; Infection, Bacterial

Treatments: Device: Standard sinus rinse; Device: Manuka honey sinus rinse

Study type: Interventional

Funder types: Other

Identifiers

NCT04589897

JMR1075-100

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 2 patient groups

Experimental

Experimental group

Description:

Manuka honey sinus rinse

Treatment:

Device: Manuka honey sinus rinse

Standard

Active Comparator group

Description:

Standard sinus rinse

Treatment:

Device: Standard sinus rinse