LC-Plasma for Preventing URTIs and Reducing Symptoms | NCT06827327

Studies
LC-Plasma for Preventing URTIs and Reducing Symptoms

NCT06827327

Sponsor

RDC Clinical Pty Ltd

Status

Completed

Last Update Posted

Mar 6, 2026Actual

Enrollment

637Actual

Phase

Phase 3

Conditions

Healthy Volunteer
URTI

Interventions

LC-Plasma
Placebo

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 28, 2025Actual

Primary Completion Date

Jan 10, 2026Actual

Completion Date

Jan 10, 2026Actual

First Submitted Date

Feb 10, 2025

First Submission Date that Met QC Criteria

Feb 10, 2025

First Posted Date

Feb 14, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2026

Last Update Posted Date

Mar 6, 2026Actual

Name	Class
Kirin Holdings Company, Limited	INDUSTRY

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

637Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
LC-Plasma	Dietary Supplement	1 tablet containing 50mg LC-Plasma is taken daily for 24 weeks	LC-Plasma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cumulative incidence number of URTIs	Cumulative incidence number of Upper Respiratory Tract Infections (URTIs)	Day 1 to 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Cumulative number of infected participants	Cumulative number of infected participants	Day 1 to week 24
Cumulative number of days that participant recorded symptom positive to WURSS-24 system

Other Outcomes

Measure	Description	Time Frame
Safety: Occurrence of adverse events and Serious Adverse Events	Occurrence of adverse events and Serious Adverse Events	Day 1 to week 24

Eligibility Module

Eligibility Criteria

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

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Yusuke Ushida	Kirin Holdings Company, Limited	Study Director
Osamu Kanauchi	Kirin Holdings Company, Limited	Study Director