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Completed

NCT Number: NCT04589897

Manuka Honey Sinus Rinse Study

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

All Wales Adult Cystic Fibrosis Center, University Hospital Llandough

Cardiff, CF62 2XX, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manuka honey sinus rinse

Device

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

Standard sinus rinse

Device

will follow the standard NHS nasal rinse protocol

Primary outcomes

  1. Change in Sino-Nasal Outcome Test 22 (SNOT- 22) Score

    Time frame: 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 outcomes

  1. Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score

    Time frame: 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

  2. Bacterial type and number

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Swansea University

Other

Collaborators

  • University Hospital of Wales

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 19, 2020
Registry last updated
Sep 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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