Clinical trial NCT04589897: Manuka Honey Sinus Rinse Study
Official title: A Pilot Study Investigating the Effects of a Manuka Honey Sinus Rinse on Sino-nasal Outcome Test Scores in Cystic Fibrosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Infection, Bacterial
Lead sponsor: Swansea University
Sponsor class: OTHER
Collaborators: name: University Hospital of Wales
First posted: 2020-10-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Sino-Nasal Outcome Test 22 (SNOT- 22) Score
timeFrame: Baseline and day 30 (+-7 days)
Secondary outcomes:
measure: Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score
timeFrame: Baseline and day 30 (+-7 days)
measure: Bacterial type and number
timeFrame: Baseline and day 30 (+-7 days)
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: All Wales Adult Cystic Fibrosis Center, University Hospital Llandough
Study officials:
affiliation: National Health Service, United Kingdom
name: Jamie Duckers
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.