NCT06837961

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2025

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

April 29, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2025

Completed
Last Updated

November 18, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

February 17, 2025

Last Update Submit

November 16, 2025

Conditions

Healthy VolunteerImmune Response

Keywords

LC-PlasmaHealthy volunteer

Outcome Measures

Primary Outcomes (1)

  • The degree of activation of plasmacytoid dendritic cells (pDCs)

    The degree of activation of plasmacytoid dendritic cells (pDCs) is measured using the indicators CD304+/CD123+, CD86+, or HLA-DR+

    Week 0 to week 4

Secondary Outcomes (4)

  • Activation of Cytotoxic T Lymphocytes (CTLs)

    Week 0 to week 4

  • Anti-viral Activity of PBMCs

    Week 0 to week 4

  • WURSS-24 Symptom Score

    Week 0 to week 4

  • Rapid antigen test (RAT)

    Week 0 to week 4

Other Outcomes (2)

  • Safety: Occurrence of adverse events

    Week 0 to week 4

  • Safety: Confirmation of medical history during study period

    Week 0 to week 4

Study Arms (2)

LC-Plasma

EXPERIMENTAL

1 tablet containing 50mg LC-Plasma is taken daily for 4 weeks

Dietary Supplement: LC-Plasma

Placebo

PLACEBO COMPARATOR

1 tablet containing 50mg microcrystalline cellulose is taken daily for 4 weeks

Other: Placebo

Interventions

LC-PlasmaDIETARY_SUPPLEMENT

1 tablet containing 50mg LC-Plasma is taken daily for 4 weeks

LC-Plasma
PlaceboOTHER

1 tablet containing 50mg MCC is taken daily for 4 weeks

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Griffith University

Southport, Queensland, 4215, Australia

Location

Study Officials

  • Yusuke Ushida

    Kirin Holdings Company, Limited

    STUDY DIRECTOR

  • Osamu Kanauchi

    Kirin Holdings Company, Limited

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2025

First Posted

February 20, 2025

Study Start

April 29, 2025

Primary Completion

November 3, 2025

Study Completion

November 3, 2025

Last Updated

November 18, 2025

Record last verified: 2025-02

Locations

AU(1)