Cystic FibrosisNCT04589897
Manuka Honey Sinus Rinse Study
A study testing Manuka honey sinus rinse and Standard sinus rinse in people with Cystic Fibrosis and Infection, Bacterial, run by Swansea University at 1 site in United Kingdom.
Trial summary
A trial investigating the effect of a sinus rinse in people with CF Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis, Infection, Bacterial
- What is being tested?
- Manuka honey sinus rinse and Standard sinus rinse
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jan 2019to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
All Wales Adult Cystic Fibrosis Center, University Hospital Llandough
Cardiff, CF62 2XX
About this 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
A trial investigating the effect of a sinus rinse in people with CF
Read the 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.
- Conditions
- Cystic Fibrosis, Infection, Bacterial
- Being tested
- Manuka honey sinus rinse, Standard sinus rinse
- Medical subject headings
- Cystic Fibrosis, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manuka honey sinus rinseDevice
Will follow a modified NHS nasal rinse protocol with the addition of manuka honey
Standard sinus rinseDevice
will follow the standard NHS nasal rinse protocol
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Manuka honey sinus rinse Receives: Device: Manuka honey sinus rinse |
| Standard | Active comparator | Standard sinus rinse Receives: Device: Standard sinus rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and day 30 (+-7 days)
Secondary outcomes (2)
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
Measured: Baseline and day 30 (+-7 days)
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
Measured: Baseline and day 30 (+-7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start7 Jan 2019
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swansea University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Wales
- Responsible party
- Sponsor
- Investigators
- Jamie Duckers, Principal investigator, National Health Service, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589897
- Sponsor's protocol ID
- JMR1075-100
- Status last verified
- Oct 2021
- First submitted
- 24 Sep 2020
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data collected during the trial that underlie the results to be reported in an article after deidentification.
Publications
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.
PubMed 36153609
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Investigating the Effects of a Manuka Honey Sinus Rinse on Sino-nasal Outcome Test Scores in Cystic Fibrosis Patients
- ClinicalTrials.gov ID
- NCT04589897
- Acronym / sponsor ID
- JMR1075-100
- Conditions
- Cystic Fibrosis, Infection, Bacterial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Swansea UniversityUniversity, hospital or other
- Collaborators
- University Hospital of Wales
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Manuka honey sinus rinseManuka honey sinus rinse |
| Standard | Active comparator | Device: Standard sinus rinseStandard sinus rinse |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manuka honey sinus rinseWill follow a modified NHS nasal rinse protocol with the addition of manuka honey | Device | Experimental |
| Standard sinus rinsewill follow the standard NHS nasal rinse protocol | Device | Standard |
Primary outcome
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
2 secondary outcomes
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score
Time frame: Baseline and day 30 (+-7 days)
Bacterial type and number
Time frame: Baseline and day 30 (+-7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Derived from this study: PubMed 36153609Roberts 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.
- Individual participant dataSharing planned: Yes. Individual participant data collected during the trial that underlie the results to be reported in an article after deidentification.
Related trials for Cystic Fibrosis
RecruitingObservational study
PERCE-MUCO: Perceptions and Expectations of People With Cystic Fibrosis Regarding a Change in Treatment
Cystic Fibrosis (CF)
Active, not recruitingObservational study
Sleep Quality in Patients With Non-cystic Fibrosis Bronchiectasis
Bronchiectasis, Sleep-Disordered Breathing
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Novel Point-of-care Sweat Chloride Testing Device for Monitoring CFTR Function
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Active, not recruitingPhase 1
A Phase 1 Relative Bioavailability Study of a VX-581 Tablet Formulation
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A Phase II Study of Ensifentrine in Non-Cystic Fibrosis Bronchiectasis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie Duckers principal investigator
National Health Service, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manuka honey sinus rinse and Standard sinus rinse in people with Cystic Fibrosis and Infection, Bacterial, run by Swansea University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sino-Nasal Outcome Test 22 (SNOT- 22) Score (time frame: Baseline and day 30 (+-7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04589897, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.