Healthy VolunteerPhase 3NCT06827327
LC-Plasma for Preventing URTIs and Reducing Symptoms
A Phase 3 study testing LC-Plasma in people with Healthy Volunteer and URTI, run by RDC Clinical Pty Ltd at 1 site in Australia.
Trial summary
The goal of this study is to evaluate the efficacy of the LC-Plasma in preventing upper respiratory tract infections (URTIs) in healthy volunteers. Researchers will compare LC-Plasma to placebo to see if LC-Plasma prevents URTIs. Participants will take a tablet containing LC-Plasma or placebo daily for 24 weeks. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, URTI
- What is being tested?
- LC-Plasma
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 637 participants
- Where
- 1 siteAustralia
- Study dates
- 28 Mar 2025to 10 Jan 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
The goal of this study is to evaluate the efficacy of the LC-Plasma in preventing upper respiratory tract infections (URTIs) in healthy volunteers. Researchers will compare LC-Plasma to placebo to see if LC-Plasma prevents URTIs. Participants will take a tablet containing LC-Plasma or placebo daily for 24 weeks.
- Conditions
- Healthy Volunteer, URTI
- Being tested
- LC-Plasma, Placebo
- Keywords
- LC-Plasma, URTI, Healthy volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LC-PlasmaDietary supplement
1 tablet containing 50mg LC-Plasma is taken daily for 24 weeks
PlaceboOther
1 tablet containing 50mg MCC is taken daily for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| LC-Plasma | Experimental | 1 tablet containing 50mg LC-Plasma is taken daily for 24 weeks. Receives: Dietary Supplement: LC-Plasma |
| Placebo | Placebo comparator | 1 tablet containing 50mg microcrystalline cellulose is taken daily for 24 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence number of URTIs
Cumulative incidence number of Upper Respiratory Tract Infections (URTIs)
Measured: Day 1 to 24 weeks
Secondary outcomes (4)
Cumulative number of infected participants
Cumulative number of infected participants
Measured: Day 1 to week 24
Cumulative number of days that participant recorded symptom positive to WURSS-24 system
Cumulative number of days that participant recorded symptom positive to WURSS-24 (Wisconsin Upper Respiratory Symptom Survey) scoring system during intervention period.
Measured: Day 1 to week 24
Cumulative scores of each parameter in WURSS-24 scoring system, as well as the total sum of all parameters for each participant.
Cumulative scores of each parameter in WURSS-24 scoring system during the intervention period, as well as the total sum of all parameters for each participant.
Measured: Day 1 to week 24
Length of URTI symptomatic days per one URTI episode.
Length of Upper Respiratory Tract Infection (URTI) symptomatic days per one URTI episode.
Measured: Day 1 to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start28 Mar 2025
- Primary completion10 Jan 2026
- Study completion10 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 637 participants (actual)
Sponsor and investigators
- Lead sponsor
- RDC Clinical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kirin Holdings Company, Limited
- Responsible party
- Sponsor
- Investigators
- Yusuke Ushida, Study director, Kirin Holdings Company, LimitedOsamu Kanauchi, Study director, Kirin Holdings Company, Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827327
- Sponsor's protocol ID
- KURTIS
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06827327
- Acronym / sponsor ID
- KURTIS
- Conditions
- Healthy Volunteer, URTI
- Keywords
- LC-Plasma, URTI, Healthy volunteer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 637 participants (actual)
- Lead sponsor
- RDC Clinical Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Kirin Holdings Company, Limited
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 10 Jan 2026 (actual)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate the efficacy of the LC-Plasma in preventing upper respiratory tract infections (URTIs) in healthy volunteers. Researchers will compare LC-Plasma to placebo to see if LC-Plasma prevents URTIs. Participants will take a tablet containing LC-Plasma or placebo daily for 24 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LC-Plasma | Experimental | Dietary Supplement: LC-Plasma1 tablet containing 50mg LC-Plasma is taken daily for 24 weeks. |
| Placebo | Placebo comparator | Other: Placebo1 tablet containing 50mg microcrystalline cellulose is taken daily for 24 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LC-Plasma1 tablet containing 50mg LC-Plasma is taken daily for 24 weeks | Dietary supplement | LC-Plasma |
| Placebo1 tablet containing 50mg MCC is taken daily for 24 weeks | Other | Placebo |
Primary outcome
Cumulative incidence number of URTIs
Time frame: Day 1 to 24 weeks
Cumulative incidence number of Upper Respiratory Tract Infections (URTIs)
4 secondary outcomes
Cumulative number of infected participants
Time frame: Day 1 to week 24
Cumulative number of days that participant recorded symptom positive to WURSS-24 system
Time frame: Day 1 to week 24
Cumulative scores of each parameter in WURSS-24 scoring system, as well as the total sum of all parameters for each participant.
Time frame: Day 1 to week 24
Length of URTI symptomatic days per one URTI episode.
Time frame: Day 1 to week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yusuke Ushida study director
Kirin Holdings Company, Limited
Osamu Kanauchi study director
Kirin Holdings Company, Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LC-Plasma in people with Healthy Volunteer and URTI, run by RDC Clinical Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence number of URTIs (time frame: Day 1 to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.