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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06837961
Registration number
NCT06837961
Ethics application status
Date submitted
17/02/2025
Date registered
20/02/2025
Date last updated
24/06/2025
Titles & IDs
Public title
LC-Plasma on Immune Response and Reducing Symptoms of Upper Respiratory Infectious Diseases
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Scientific title
The Effects of Lactococcus Lactis JCM 5805 (LC-Plasma) Lactic Acid Bacteria on Immune Response and Reducing Symptoms of Upper Respiratory Infectious Disease in Australian Healthy Adults.
Randomized Placebo-controlled Double-blind Parallel Group Study.
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Secondary ID [1]
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GU/2025/073
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteer
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Immune Response
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Infection
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Sexually transmitted infections
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Intervention/exposure
Study type
Interventional
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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 4 weeks
Placebo comparator: Placebo - 1 tablet containing 50mg microcrystalline cellulose is taken daily for 4 weeks
Treatment: Other: LC-Plasma
1 tablet containing 50mg LC-Plasma is taken daily for 4 weeks
Other interventions: Placebo
1 tablet containing 50mg MCC is taken daily for 4 weeks
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The degree of activation of plasmacytoid dendritic cells (pDCs)
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Assessment method [1]
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The degree of activation of plasmacytoid dendritic cells (pDCs) is measured using the indicators CD304+/CD123+, CD86+, or HLA-DR+
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Timepoint [1]
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Week 0 to week 4
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Secondary outcome [1]
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Activation of Cytotoxic T Lymphocytes (CTLs)
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Assessment method [1]
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The evaluation of CTLs responsible for virus elimination will be determined using the indicator (CD8+/CD3+/CD4-/IFN-?+).
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Timepoint [1]
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Week 0 to week 4
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Secondary outcome [2]
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Anti-viral Activity of PBMCs
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Assessment method [2]
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The anti-viral activity gene expression and IFN-a \& ß production capability of PBMCs, both unstimulated and mildly stimulated with CpG, will be measured.
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Timepoint [2]
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Week 0 to week 4
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Secondary outcome [3]
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WURSS-24 Symptom Score
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Assessment method [3]
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Symptoms will be measured using the Wisconsin Upper Respiratory Symptom Survey (WURSS-24)
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Timepoint [3]
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Week 0 to week 4
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Secondary outcome [4]
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Rapid antigen test (RAT)
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Assessment method [4]
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Rapid antigen test (RAT) for Flu A/B, RSV \& SARS-CoV-2. Will be conducted by participants once per week, with additional tests if symptoms are present.
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Timepoint [4]
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Week 0 to week 4
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Eligibility
Key inclusion criteria
* Individuals who can provide a signed and dated informed consent form after confirming their willingness to participate.
* Individuals willing to comply with all study procedures during the study period, including daily monitoring record compliance, cooperating with blood and urine sample collection and performing regular RATs.
* Healthy people living in Australia aged 18-60 (both men and women).
* Individuals who have received at least two doses of a SARS-CoV-2 vaccine, with at least two weeks having passed since the last dose.
* Individuals who are not currently infected with SARS-CoV-2 and, if previously infected, have recovered and have been infection-free for at least four weeks.
* Individuals who do not have any chronic or acute illnesses, including respiratory and/or gastrointestinal and/or other diseases, (e.g. hypertension, IBS, IBD, SLE, cancer, asthma, primary or secondary immunodeficiencies etc.), at the time of enrolment.
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Individuals medically prescribed medications that would affect the immune and/or the inflammatory response.
* Individuals deemed unsuitable for participation by Griffith CTU staff and/or the study clinician.
* Active smokers/vapers and/or individuals with nicotine or drug habits.
* Individuals currently participating in (or planning to participate in) other clinical trials.
* Women who are pregnant, planning to become pregnant during the study period, or are currently breastfeeding.
* Individuals unable to abstain from alcohol for two days prior to blood and urine sample collection.
* Individuals unable to refrain from consuming other lactic acid bacteria supplements.
* Individuals who are known to be HIV, HTLV-1, or HCV positive (based on answers to the enrolment questionnaire).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/04/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/10/2025
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Actual
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Sample size
Target
220
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Griffith University - Southport
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Recruitment postcode(s) [1]
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4215 - Southport
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
RDC Clinical Pty Ltd
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Kirin Holdings Company, Limited
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The goal of this study is to evaluate the effects of LC-Plasma on the innate and acquired immune systems, including the activation of pDCs, which play a role in virus elimination, as well as to assess its efficacy in reducing clinical symptoms of upper respiratory infectious diseases in healthy adults. Researchers will compare LC-Plasma to placebo, participants will take a tablet containing LC-Plasma or placebo daily for 4 weeks.
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Trial website
https://clinicaltrials.gov/study/NCT06837961
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Yusuke Ushida
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Address
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Kirin Holdings Company, Limited
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Suresh Mahalingam
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Address
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Country
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Phone
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+61 (0) 406 166 671
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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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/NCT06837961
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