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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06827327




Registration number
NCT06827327
Ethics application status
Date submitted
10/02/2025
Date registered
14/02/2025

Titles & IDs
Public title
LC-Plasma for Preventing URTIs and Reducing Symptoms
Scientific title
A Randomized Controlled Trial Evaluating the Efficacy of Lactococcus Lactis JCM 5805 (LC-Plasma) Lactic Acid Bacteria in Preventing Upper Respiratory Tract Infections and Reducing Symptom Severity and Duration
Secondary ID [1] 0 0
KURTIS
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteer 0 0
URTI 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - LC-Plasma
Other interventions - Placebo

Experimental: LC-Plasma - 1 tablet containing 50mg LC-Plasma is taken daily for 24 weeks.

Placebo comparator: Placebo - 1 tablet containing 50mg microcrystalline cellulose is taken daily for 24 weeks


Treatment: Other: LC-Plasma
1 tablet containing 50mg LC-Plasma is taken daily for 24 weeks

Other interventions: Placebo
1 tablet containing 50mg MCC is taken daily for 24 weeks
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cumulative incidence number of URTIs
Timepoint [1] 0 0
Day 1 to 24 weeks
Secondary outcome [1] 0 0
Cumulative number of infected participants
Timepoint [1] 0 0
Day 1 to week 24
Secondary outcome [2] 0 0
Cumulative number of days that participant recorded symptom positive to WURSS-24 system
Timepoint [2] 0 0
Day 1 to week 24
Secondary outcome [3] 0 0
Cumulative scores of each parameter in WURSS-24 scoring system, as well as the total sum of all parameters for each participant.
Timepoint [3] 0 0
Day 1 to week 24
Secondary outcome [4] 0 0
Length of URTI symptomatic days per one URTI episode.
Timepoint [4] 0 0
Day 1 to week 24

Eligibility
Key inclusion criteria
* Adults aged 18-60 years living in Australia
* Individuals with a history of recurrent upper respiratory tract infections
* Able to provide informed consent
* Generally healthy
* Agree to not participate in another clinical trial while enrolled in this trial
* Agree to maintain their usual daily activities without significant changes. This includes not changing their current diet or stopping/starting a new exercise regimen during entire study period
* Agree not to travel internationally for over 1 month in a single trip during the intervention period (baseline to study completion).
* Females of childbearing potential must a prescribed form of birth control
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Serious illness e.g., liver disease, kidney disease, heart disease, mood disorders, neurological disorders such as multiple sclerosis.
* Unstable illness e.g., changing medication/treatment.
* BMI <18.5, >30
* Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years.
* Individuals with chronic respiratory conditions (e.g., asthma, chronic obstructive pulmonary disease).
* Has current symptoms of an acute sickness.
* Active smokers, nicotine use or drug (prescription or illegal substances) abuse
* Current alcohol use (>14 alcoholic drinks week)
* Allergic to any of the ingredients in the active or placebo formula
* Pregnant or lactating woman
* People medically prescribed medications within the last month that would affect the immune and/or the inflammatory response excluding topical steroid use.
* Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month
* Participants with cognitive damage
* Participants with seasonal allergic rhinitis
* Regular use of antihistamines
* Individuals deemed unsuitable for participation by the Principal Investigator (PI) of this study.

Study design
Purpose of the study
Prevention
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 receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
Actual
28/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
RDC Clinical - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
RDC Clinical Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Kirin Holdings Company, Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Yusuke Ushida
Address 0 0
Kirin Holdings Company, Limited
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amanda Rao
Address 0 0
Country 0 0
Phone 0 0
+61 (0) 414 488 559
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT06827327