Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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 details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05624177




Registration number
NCT05624177
Ethics application status
Date submitted
14/11/2022
Date registered
22/11/2022
Date last updated
23/11/2022

Titles & IDs
Public title
Colonisation Efficacy of a Probiotic Chewing Gum.
Scientific title
Colonisation Efficacy of a Probiotic Chewing Gum.
Secondary ID [1] 0 0
BLTCT2022/7
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Microbial Colonization 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active comparator: Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum: Chew 5 minutes - Streptococcus salivarius M18 chewing gum 1 billion cfu chewing the gum for 5 minutes duration.

Experimental: SARS-CoV-2 beta S vaccine arm 3 - SARS-CoV-2 beta S vaccine Antigen dose 2, adjuvant dose 1, IM

Active comparator: Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum: Chew 10 minutes - Streptococcus salivarius M18 chewing gum 1 billion cfu chewing the gum for 10 minutes duration.
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
* In general, good health
* Practice good oral hygiene
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Have a history of autoimmune disease or are immune compromised.
* Are on concurrent antibiotic therapy, or regular antibiotic use within last one week
* People with allergies or sensitivities to dairy.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/12/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2023
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BLIS Technologies Limited
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
John D Hale, PhD
Address 0 0
Country 0 0
Phone 0 0
+64211735540
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05624177