Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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 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
Sex
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
10/06/2019
Actual
9/09/2019
Date of last participant enrolment
Anticipated
30/08/2019
Actual
6/12/2019
Date of last data collection
Anticipated
31/12/2019
Actual
28/02/2020
Sample size
Target
40
Accrual to date
Final
50
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
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
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
Trial website
Trial related presentations / publications
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
[email protected]
Contact person for public queries
Name 92343 0
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
[email protected]
Contact person for scientific queries
Name 92344 0
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
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• data will be made readily accessible to the research team, including supervisors and bio-statistician.

Conditions for requesting access:
• -

What individual participant data might 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

What types of analyses could be done with individual participant data?
• data will be available for descriptive analysis

When can requests for individual participant data be made (start and end dates)?
From:
data will be available at the completion of the trial period approximately 31/12/2019 with no end date of availability

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• data will be summarised and presented in tabular and graphical form for the final publication

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Documents were uploaded by study researchers but have since been removed.

Documents added automatically
No additional documents have been identified.