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Manuka Honey Sinus Rinse Study

Primary Purpose

Cystic Fibrosis, Infection, Bacterial

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Manuka honey sinus rinse
Standard sinus rinse
Sponsored by
Swansea University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cystic Fibrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • All Wales Adult Cystic Fibrosis Center, University Hospital Llandough

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Standard

Arm Description

Manuka honey sinus rinse

Standard sinus rinse

Outcomes

Primary Outcome Measures

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

Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score
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
Bacterial type and number
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

Full Information

First Posted
September 24, 2020
Last Updated
September 20, 2022
Sponsor
Swansea University
Collaborators
University Hospital of Wales
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1. Study Identification

Unique Protocol Identification Number
NCT04589897
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swansea University
Collaborators
University Hospital of Wales

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Infection, Bacterial

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Manuka honey sinus rinse
Arm Title
Standard
Arm Type
Active Comparator
Arm Description
Standard sinus rinse
Intervention Type
Device
Intervention Name(s)
Manuka honey sinus rinse
Intervention Description
Will follow a modified NHS nasal rinse protocol with the addition of manuka honey
Intervention Type
Device
Intervention Name(s)
Standard sinus rinse
Intervention Description
will follow the standard NHS nasal rinse protocol
Primary Outcome Measure Information:
Title
Change in Sino-Nasal Outcome Test 22 (SNOT- 22) Score
Description
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
Time Frame
Baseline and day 30 (+-7 days)
Secondary Outcome Measure Information:
Title
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score
Description
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
Time Frame
Baseline and day 30 (+-7 days)
Title
Bacterial type and number
Description
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
Time Frame
Baseline and day 30 (+-7 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie Duckers
Organizational Affiliation
National Health Service, United Kingdom
Official's Role
Principal Investigator
Facility Information:
Facility Name
All Wales Adult Cystic Fibrosis Center, University Hospital Llandough
City
Cardiff
ZIP/Postal Code
CF62 2XX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data collected during the trial that underlie the results to be reported in an article after deidentification.
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication.
IPD Sharing Access Criteria
Anyone who wishes to access the data.
Citations:
PubMed Identifier
36153609
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.
Results Reference
derived

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Manuka Honey Sinus Rinse Study

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