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Manuka Honey Sinus Rinse Study

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ClinicalTrials.gov Identifier: NCT04589897
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : August 9, 2021
Sponsor:
Collaborator:
University Hospital of Wales
Information provided by (Responsible Party):
Swansea University

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

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Infection, Bacterial Device: Manuka honey sinus rinse Device: Standard sinus rinse Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Pilot Study Investigating the Effects of a Manuka Honey Sinus Rinse on Sino-nasal Outcome Test Scores in Cystic Fibrosis Patients
Actual Study Start Date : January 7, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: Experimental
Manuka honey sinus rinse
Device: Manuka honey sinus rinse
Will follow a modified NHS nasal rinse protocol with the addition of manuka honey

Active Comparator: Standard
Standard sinus rinse
Device: Standard sinus rinse
will follow the standard NHS nasal rinse protocol




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04589897


Contacts
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Contact: Rowena Jenkins 00 441792 602951 r.e.jenkins@swansea.ac.uk

Locations
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United Kingdom
All Wales Adult Cystic Fibrosis Center, University Hospital Llandough Recruiting
Cardiff, United Kingdom, CF62 2XX
Contact: Jamie Duckers    02920 716488    Jamie.Duckers@wales.nhs.uk   
Sponsors and Collaborators
Swansea University
University Hospital of Wales
Investigators
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Principal Investigator: Jamie Duckers National Health Service, United Kingdom
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Responsible Party: Swansea University
ClinicalTrials.gov Identifier: NCT04589897    
Other Study ID Numbers: JMR1075-100
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: August 9, 2021
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data collected during the trial that underlie the results to be reported in an article after deidentification.
Supporting Materials: Study Protocol
Time Frame: Beginning 3 months and ending 5 years following article publication.
Access Criteria: Anyone who wishes to access the data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bacterial Infections
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Bacterial Infections and Mycoses
Infections