ANZCTR - Registration

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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 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]

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

Condition category

Condition code

Alternative and Complementary Medicine

Other alternative and complementary medicine

Infection

Studies of infection and infectious agents

Ear

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]

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]

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]

nasopharyngeal swab taken at the conclusion of the washout period, followed by one other at the 3 months mark.

Secondary outcome [1]

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]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Canterbury

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Tzu-Yu Chen

Address [1]

ENT Department
5th Floor Riverside Building
Christchurch Hospital
2 Riccarton Ave
Christchurch 8011

Country [1]

New Zealand

Primary sponsor type

Commercial sector/Industry

Name

BLIS technologies

Address

81 Glasgow St,
Dunedin, 9012

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disabiltiy Ethics Committee New Zealand

Ethics committee address [1]

Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

05/04/2019

Approval date [1]

03/09/2019

Ethics approval number [1]

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

Dr Tzu Yu Chen

Address

ENT Department
5th Floor Riverside Building
Christchurch Public Hospital
2 Riccarton Ave
Christchurch
8011

Country

New Zealand

Phone

+64212068999

Fax

tychen87@gmail.com

Contact person for public queries

Name

Tzu Yu Chen

Address

ENT Department
5th Floor Riverside Building
Christchurch Public Hospital
2 Riccarton Ave
Christchurch
8011

Country

New Zealand

Phone

+64212068999

Fax

tychen87@hotmail.com

Contact person for scientific queries

Name

Tzu Yu Chen

Address

ENT Department
5th Floor Riverside Building
Christchurch Public Hospital
2 Riccarton Ave
Christchurch
8011

Country

New Zealand

Phone

+64212068999

Fax

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?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Basic results	No			377321-(Uploaded-30-12-2020-19-29-28)-Basic results summary.docx

Documents added automatically

No additional documents have been identified.

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