Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000154505
Ethics application status
Approved
Date submitted
4/02/2015
Date registered
17/02/2015
Date last updated
17/02/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of Xylitol and Saline Nasal Irrigations on the Sinus Microbiome in Patients with Chronic Rhinosinusitis
Scientific title
The effect of xylitol and saline nasal irrigations on the microbiome of patients with chronic sinusitis, a study by the Department of Surgery, University of Auckland.
Secondary ID [1] 286101 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Sinusitis 294102 0
Condition category
Condition code
Inflammatory and Immune System 294413 294413 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pilot RCT - Thirty patients with a diagnosis of chronic rhinosinusitis (CRS) and attending a specialist rhinology clinic, will be recruited into this study.

Microbiological swabs will be taken from suitably recruited CRS patients for bacterial culture and microbacterial analysis. Nasal swabs will be performed under endoscopic guidance after application of local anaesthesia spray.

Patients will be randomised to receive either saline or xylitol nasal rinse.

Arm1
Patients randomised to receive xylitol will be supplied with xylitol and given instructions to make a 4% solution which will be used three times daily for two weeks.

Arm2
Patients in the saline group will be given instructions to make a physiological saline solution using sea salt, which will also be used three times daily for two weeks. At the end of that two week period, patients will return to the clinic for re-assessment where further swabs are taken.

Monitoring of therapy will be by completion of a patient diary template.
Intervention code [1] 291094 0
Treatment: Other
Comparator / control treatment
As swabs are taken before and after therapy, each patient will serve as their own control. Saline nasal rinse will be considered to be the comparator treatment.
Control group
Active

Outcomes
Primary outcome [1] 294206 0
Microbiology swabs are taken from CRS patients attending the specialist rhinology clinics. Laboratory analysis of the swabs will be undertaken before and after therapy and will be compared. The primary endpoint is mucous microbiology.
Timepoint [1] 294206 0
Swabs before and after two weeks of therapy.
Secondary outcome [1] 312767 0
Nil
Timepoint [1] 312767 0
Nil

Eligibility
Key inclusion criteria
Patients diagnosed with chronic rhinosinusitis
Patients providing full-informed consent to participate in this study
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Children (<16 years)
2. Cystic fibrosis
3. Immunodeficiency (congenital or acquired)
4. Congenital mucociliary problems (e.g. primary ciliary dyskinesia)
5. Non-invasive and invasive fungal sinus disease
6. Systemic vasculitis and granulomatous diseases
7. History of cocaine abuse;
8. Patients requiring sinus surgery for neoplasia
9. Patients unable to consent (e.g. lack of mental capacity)

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)
Central randomisation by computer database
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Central randomisation by computer database
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As the effect size for these interventions is not known, this study serves as a pilot RCT.

Analysis of variance for changes within an individual following treatment and differences of means within groups will be assessed. Alpha and beta diversity of microbial communities will be analysed. Statistical significance will be accepted at the 0.05 level.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/02/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 6627 0
New Zealand
State/province [1] 6627 0

Funding & Sponsors
Funding source category [1] 290681 0
Self funded/Unfunded
Name [1] 290681 0
NA
Country [1] 290681 0
Primary sponsor type
Individual
Name
Associate Professor Richard Douglas
Address
Department of Surgery
The University of Auckland
Level 12, Room 12-087, ACH Support Building, Park Road, Grafton. 1142
Country
New Zealand
Secondary sponsor category [1] 289375 0
Individual
Name [1] 289375 0
Mr Samuel Leong
Address [1] 289375 0
Department of Surgery
The University of Auckland
Level 12, Room 12-087, ACH Support Building, Park Road, Grafton. 1142
Country [1] 289375 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292312 0
New Zealand HDEC
Ethics committee address [1] 292312 0
Ministry of Health
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013 Wellington. 6011
Ethics committee country [1] 292312 0
New Zealand
Date submitted for ethics approval [1] 292312 0
Approval date [1] 292312 0
18/11/2014
Ethics approval number [1] 292312 0
14/NTB/141

Summary
Brief summary
The presence of biofilms within the paranasal sinuses have been correlated to poorer clinical outcomes following treatment for chronic rhinosinusitis. In light of the resistance of biofilm bacteria to conventional antibiotics, a number of novel approaches for treating biofilms have been proposed, including physical removal of the biofim by irrigation, interfering with chemical communication between micro-organisms or degrading the biofilm matrix with enzymes.

The effect of Xylitol on the microbiome of CRS has not yet been evaluated. It is hypothesised that xylitol may be an effective method for reducing biofilms and improving outcomes in CRS. If Xylitol nasal irrigation can reduce the bacterial burden within CRS sinuses, this simple, safe and effective treatment would be an invaluable, non-antibiotic addition to the treatment options for CRS.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54638 0
A/Prof Richard Douglas
Address 54638 0
Department of Surgery University of Auckland Private Bag 92019 Auckland Mail Centre 1142
Country 54638 0
New Zealand
Phone 54638 0
+64 27 2186083
Fax 54638 0
Email 54638 0
[email protected]
Contact person for public queries
Name 54639 0
Dr Ravi Jain
Address 54639 0
Department of Surgery University of Auckland Private Bag 92019 Auckland Mail Centre 1142
Country 54639 0
New Zealand
Phone 54639 0
+64 21 728452
Fax 54639 0
Email 54639 0
[email protected]
Contact person for scientific queries
Name 54640 0
Dr Ravi Jain
Address 54640 0
Department of Surgery University of Auckland Private Bag 92019 Auckland Mail Centre 1142
Country 54640 0
New Zealand
Phone 54640 0
+64 21 728452
Fax 54640 0
Email 54640 0
[email protected]

No information has been provided regarding IPD availability


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.