NCT06827327

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
637

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 14, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

March 28, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2026

Completed
Last Updated

March 6, 2026

Status Verified

February 1, 2025

Enrollment Period

10 months

First QC Date

February 10, 2025

Last Update Submit

March 4, 2026

Conditions

Healthy VolunteerURTI

Keywords

LC-PlasmaURTIHealthy volunteer

Outcome Measures

Primary Outcomes (1)

  • Cumulative incidence number of URTIs

    Cumulative incidence number of Upper Respiratory Tract Infections (URTIs)

    Day 1 to 24 weeks

Secondary Outcomes (4)

  • Cumulative number of infected participants

    Day 1 to week 24

  • Cumulative number of days that participant recorded symptom positive to WURSS-24 system

    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.

    Day 1 to week 24

  • Length of URTI symptomatic days per one URTI episode.

    Day 1 to week 24

Other Outcomes (1)

  • Safety: Occurrence of adverse events and Serious Adverse Events

    Day 1 to week 24

Study Arms (2)

LC-Plasma

EXPERIMENTAL

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

Dietary Supplement: LC-Plasma

Placebo

PLACEBO COMPARATOR

1 tablet containing 50mg microcrystalline cellulose is taken daily for 24 weeks

Other: Placebo

Interventions

LC-PlasmaDIETARY_SUPPLEMENT

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

LC-Plasma
PlaceboOTHER

1 tablet containing 50mg MCC is taken daily for 24 weeks

Placebo

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RDC Clinical

Brisbane, Queensland, 4006, 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
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2025

First Posted

February 14, 2025

Study Start

March 28, 2025

Primary Completion

January 10, 2026

Study Completion

January 10, 2026

Last Updated

March 6, 2026

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)