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Trial registered on ANZCTR


Registration number
ACTRN12616000136404
Ethics application status
Approved
Date submitted
12/01/2016
Date registered
5/02/2016
Date last updated
27/11/2019
Date data sharing statement initially provided
27/11/2019
Date results provided
27/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot, comparative, randomized, controlled trial assessing the safety and efficacy of manuka honey in the treatment of sinonasal bacterial infections in chronic rhinosinusitis
Scientific title
Pilot, comparative, randomized controlled trial assessing the safety and efficacy of manuka honey augmented with methylglyoxal targeting bacterial infections and biofilms in patients with Chronic Rhinosinusitis in a clinical setting
Secondary ID [1] 287271 0
Nil
Universal Trial Number (UTN)
U1111-1173-1933
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic rhinosinusitis 295897 0
Condition category
Condition code
Infection 296147 296147 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in the treatment group will receive 28 pre-prepared sinonasal flush bottles containing 240mL of 16.5% manuka honey and 1.3mg/mL methylglyoxal. They will be asked to utilize the flushes twice daily for 14 days. They will also receive 20 encapsulated dextrose tablets and will be requested to take these orally twice a day for 10 days in parallel with the honey flushes.

Patients are asked to return any unused bottles and/or tablets at the end of the study to monitor treatment adherence.
Intervention code [1] 292578 0
Treatment: Other
Comparator / control treatment
Patients in the control group will receive 28 pre-prepared sinonasal flush bottles containing an isotonic saline solution. They will be asked to utilize the flushes twice daily for 14 days. They will also receive 20 culture directed antibiotic tablets and will be requested to take these orally twice a day for 10 days.

The antibiotic to be employed will be selected by the treating doctor and will be culture directed, depending on the bacterial pathogen in question and the pathogens sensitivity to antibiotics. Due to this the dosage will also vary and again this will be determined by the treating doctor.

Patients are asked to return any unused bottles and/or tablets at the end of the study to monitor treatment adherence.
Control group
Active

Outcomes
Primary outcome [1] 295834 0
Removal of active infection. This will be assess through endoscopic evaluation of the nose as well as by taking a swab from the patients nose to identify if any pathogenic bacteria are present.
Timepoint [1] 295834 0
Immediately post-treatment
Primary outcome [2] 295835 0
Assessment of endoscopic score. This will be assessed by endoscopically examining the nasal passage of the patients and recording this examination. The video will then be scored by a blinded observer using the Lund-Kennedy scoring system.
Timepoint [2] 295835 0
Immediately post-treatment
Primary outcome [3] 297116 0
Assessing the safety of the manuka honey flushes. This will be done by having patients self report any discomfort, pain or health problems that occur during the treatment period.
Timepoint [3] 297116 0
Immediately post-treatment
Secondary outcome [1] 316626 0
Assessment of symptom scores. This will be assessed by asking patients to fill in two questionnaires regarding their symptoms. This will utilize the two validated questionnaires the SNOT-22 and Visual Analogue Scale.
Timepoint [1] 316626 0
Immediately post-treatment
Secondary outcome [2] 316627 0
Prevention of future bacterial infections. This will be assessed by having patients attend clinics 3 and 6 months post-treatment to assess if they have continued to experience active infections. The nasal passage will be visualised using endoscopic techniques and if signs of an active infection are present, a swab will be taken and sent for microbiological analysis.
Timepoint [2] 316627 0
3 and 6 months post-treatment
Secondary outcome [3] 316628 0
Long term assessment of endoscopic score. This will be assessed by endoscopically examining the nasal passage of the patients and recording this examination. The video will then be scored by a blinded observer using the Lund-Kennedy scoring system.
Timepoint [3] 316628 0
3 and 6 months post-treatment
Secondary outcome [4] 320053 0
Long term assessment of symptom scores. This will be assessed by asking patients to fill in two questionnaires regarding their symptoms. This will utilize the two validated questionnaires the SNOT-22 and Visual Analogue Scale.
Timepoint [4] 320053 0
3 and 6 months post-treatment

Eligibility
Key inclusion criteria
(1) Those who have had symptoms of chronic rhinosinusitis (nasal discharge, postnasal drip, nasal obstruction, facial pain and pressure, lack of sense of smell) that has been previously persistent for greater than 3 months
(2) Have had at least one operation for their chronic rhinosinusitis
(3) Continue to have ongoing symptoms despite surgical management
(4) Have a positive sinonasal swab that indicates a bacterial infection
(5) Over 18 years of age
(6) Are able to give written informed consent
(7) Are local patients who will be returning to this centre for postoperative follow-up care
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) A diagnosis of cystic fibrosis
(2) Pregnant or breastfeeding
(3) Immunocompromised patients
(4) Patients actively taking oral steroids
(5) Patients who have used antibiotics within 1 month prior to the trial.
(6) Fructose intolerance/allergy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation will involve the investigator contacting the person who is the holder of the allocation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will be employed. This will be undertaken using the software excel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Differences between the control and treatment group will be assessed statistically using un-paired T-tests. This includes change in SNOT-22, VAS and Lund-Kennedy score. To compare the ability of control and manuka honey groups to remove the active bacterial infection, Fishers exact or chi-squared tests will be employed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/02/2016
Actual
8/02/2016
Date of last participant enrolment
Anticipated
1/02/2017
Actual
1/02/2017
Date of last data collection
Anticipated
Actual
1/11/2017
Sample size
Target
20
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 4200 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 10111 0
5011 - Woodville South

Funding & Sponsors
Funding source category [1] 291845 0
University
Name [1] 291845 0
University of Adelaide
Country [1] 291845 0
Australia
Primary sponsor type
University
Name
Adelaide University
Address
The University of Adelaide
SA 5005
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 291383 0
Hospital
Name [1] 291383 0
Department of Otolaryngology, The Queen Elizabeth Hospital
Address [1] 291383 0
Department of Otolaryngology
28 Woodville Rd
Woodville South 5011
South Australia
Country [1] 291383 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293361 0
The Queen Elizabeth Hospital, Lyell McEwin Hospital and Modbury Hospital HREC
Ethics committee address [1] 293361 0
Ethics committee country [1] 293361 0
Australia
Date submitted for ethics approval [1] 293361 0
13/07/2014
Approval date [1] 293361 0
24/08/2015
Ethics approval number [1] 293361 0
HREC/14/TQEHLMH/165

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59510 0
Prof Peter-John Wormald
Address 59510 0
The Queen Elizabeth hospital
28 Woodville Rd,
Woodville, 5011
South Australia
Country 59510 0
Australia
Phone 59510 0
+61882227158
Fax 59510 0
Email 59510 0
peterj.wormald@adelaide.edu.au
Contact person for public queries
Name 59511 0
Peter-John Wormald
Address 59511 0
The Queen Elizabeth hospital
28 Woodville Rd,
Woodville, 5011
South Australia
Country 59511 0
Australia
Phone 59511 0
+61882227158
Fax 59511 0
Email 59511 0
peterj.wormald@adelaide.edu.au
Contact person for scientific queries
Name 59512 0
Sarah Vreugde
Address 59512 0
The Queen Elizabeth hospital
28 Woodville Rd,
Woodville, 5011
South Australia
Country 59512 0
Australia
Phone 59512 0
+61882227158
Fax 59512 0
Email 59512 0
sarah.vreugde@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.