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Trial registered on ANZCTR


Registration number
ACTRN12619000779178
Ethics application status
Approved
Date submitted
30/04/2019
Date registered
27/05/2019
Date last updated
7/08/2020
Date data sharing statement initially provided
27/05/2019
Date results information initially provided
7/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Colonisation of the nasopharynx with BLIS K12 and inhibition of growth of pathogens in healthy adult volunteers.
Scientific title
Feasibility study examining the inhibitory effects of probiotics use on nasopharyngeal pathogen colonisation in healthy adult volunteers
Secondary ID [1] 297870 0
RO# 17179 - Canterbury District Health Board research office.
Universal Trial Number (UTN)
Trial acronym
Inhibitory effects of probiotics use on nasopharyngeal pathogen COloNisation Trial (ICON trial)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
otitis media 312663 0
Condition category
Condition code
Alternative and Complementary Medicine 310790 310790 0 0
Other alternative and complementary medicine
Infection 311161 311161 0 0
Studies of infection and infectious agents
Ear 311162 311162 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Enrolled participants will be given a course of oral antibiotics. An individual without penicillin allergy will be given a course of 500mg of amoxicillin twice daily for 5 days. Those with penicillin allergy will be given a course of erythromycin 800mg twice daily also for 5 days.

Participants will then be given the probiotics (BLIS K12) containing Streptococcus salivarius via the pre-determined route, whether trans-nasal drops or chewable lozenge. The determination of the route will be alternated on enrolment.

The course of probiotics will commence 1 day after the antibiotics and be given for a 2 weeks course. Both formulation (lozenge and nasal drops) of the BLIS K12 will be supplied by BLIS technologies (Dunedin) in the pre-approved commercially available form. The group with nasal drop will receive a solution prepared in sterile conditions by BLIS technologies, from freeze-dried skim-milk containing S. salivarius and suspended in sesame oil and tween 80. Both forms of probiotics will come with instruction of use and storage information. Both formulation will have 2.5 billion colony forming unit (CFU) per dose, taken twice daily.

Adherence to the regime will be monitored at the second follow up visit with the left over lozenge counted for the oral formulation and the nasal drop weighed.
Intervention code [1] 314353 0
Treatment: Other
Comparator / control treatment
Due to the small numbers in this recruitment. The ability to form comparison between the two groups will be limited and therefore the groups will be analysed individually and the results will be presented as separate groups.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319636 0
We aim to demonstrate the feasibility of colonisation of the nasopharynx by BLIS forming S. Salivarius. This will be carried out by taking a nasopharyngeal swab at the conclusion of the washout period to determine the presence of the S. Salivarius in the composition. The presence of the organism will be carried out by polymerised chain reaction.
Timepoint [1] 319636 0
nasopharyngeal swab taken at the conclusion of the washout period, followed by one other at the 3 months mark.
Secondary outcome [1] 368963 0
Nasopharyngeal swab will be lavaged with sterile solution and be prepared (specific primer added) for real time polymerised chain reaction (qPCR) to determine the presence of common otopathogens, (Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella Catarrhalis)
Timepoint [1] 368963 0
nasopharyngeal swab taken at the conclusion of the washout period, followed by one other at the 3 months mark.

Eligibility
Key inclusion criteria
All healthy adults volunteers.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Concurrent or recent (<12 weeks) use of any form of antibiotics, known allergy to BLIS products, active infection of the upper respiratory tract (including paranasal sinuses).

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Bio-availability
Statistical methods / analysis
BLIS producing organism colonisation rate will be calculated by dividing the number of volunteer that has successfully cultured BLIS organism by the total number of volunteers at the end of the study period. This summary statistics will be calculated for both groups, one that takes BLIS product by nasal drop and one group by taking oral tablets.

Composition of the nasopharyngeal flora, especailly those of the known pathogens (s. pneumoniae, H. influenzae, and M. catarrhalis) at the end of the trial period will be compared with the composition at the commencement.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21386 0
New Zealand
State/province [1] 21386 0
Canterbury

Funding & Sponsors
Funding source category [1] 302393 0
Self funded/Unfunded
Name [1] 302393 0
Tzu-Yu Chen
Address [1] 302393 0
ENT Department
5th Floor Riverside Building
Christchurch Hospital
2 Riccarton Ave
Christchurch 8011
Country [1] 302393 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
BLIS technologies
Address
81 Glasgow St,
Dunedin, 9012
Country
New Zealand
Secondary sponsor category [1] 302800 0
None
Name [1] 302800 0
Address [1] 302800 0
Country [1] 302800 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303065 0
Health and Disabiltiy Ethics Committee New Zealand
Ethics committee address [1] 303065 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 303065 0
New Zealand
Date submitted for ethics approval [1] 303065 0
05/04/2019
Approval date [1] 303065 0
03/09/2019
Ethics approval number [1] 303065 0
19/STH/117

Summary
Brief summary
We would like to conduct this scientific study to determine whether we could colonise the nasopharynx (back of the nose) with a "good bacteria" that has the ability to stop the growth of "bad bacteria that causes middle ear infection (via bacteriocin like inhibitory substance). In doing so, we would like to test it's ability of altering nasopharyngeal presence of known pathogens that causes otitis media (Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis).

To investigate this feasibility we will recruit healthy adult volunteers to be given a short course of oral antibiotics followed by a short prescribed course of nasal or oral probiotics produced by BLIS technologies containing S. Salivarius (BLIS producing organism). The recruited individual will have their nasopharynx cultured prior to probiotics to provide baseline composition. After the prescribed course of antibiotics and followed by probiotics, participants will have a "washout" time period, following this we will then culture the nasopharynx. The primary outcome will be look at the rate of colonisation by S. salivarius, and the secondary rate will be to look at the alteration in the composition of the nasopharynx of the pre determined oto-pathogens.
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 92342 0
Dr Tzu Yu Chen
Address 92342 0
ENT Department
5th Floor Riverside Building
Christchurch Public Hospital
2 Riccarton Ave
Christchurch
8011
Country 92342 0
New Zealand
Phone 92342 0
+64212068999
Fax 92342 0
Email 92342 0
tychen87@gmail.com
Contact person for public queries
Name 92343 0
Dr Tzu Yu Chen
Address 92343 0
ENT Department
5th Floor Riverside Building
Christchurch Public Hospital
2 Riccarton Ave
Christchurch
8011
Country 92343 0
New Zealand
Phone 92343 0
+64212068999
Fax 92343 0
Email 92343 0
tychen87@hotmail.com
Contact person for scientific queries
Name 92344 0
Dr Tzu Yu Chen
Address 92344 0
ENT Department
5th Floor Riverside Building
Christchurch Public Hospital
2 Riccarton Ave
Christchurch
8011
Country 92344 0
New Zealand
Phone 92344 0
+64212068999
Fax 92344 0
Email 92344 0
tychen87@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual data coded and anonymised by study number will be presented in tabular and descriptive form, including whether individual is on nasal drops or oral lozenge, their BLIS K12 count prior and post to the commencement of probiotics and also the count of the pre specified otopathogens
When will data be available (start and end dates)?
data will be available at the completion of the trial period approximately 31/12/2019 with no end date of availability
Available to whom?
data will be made readily accessible to the research team, including supervisors and bio-statistician.
Available for what types of analyses?
data will be available for descriptive analysis
How or where can data be obtained?
data will be summarised and presented in tabular and graphical form for the final publication
What supporting documents are/will be available?
Study protocol
Informed consent form
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
no results yet