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Completed

NCT Number: NCT06827327

LC-Plasma for Preventing URTIs and Reducing Symptoms

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.

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Key information

Conditions

Healthy Volunteer URTI

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

RDC Clinical

Brisbane, Queensland, 4006, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LC-Plasma

Dietary Supplement

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

Placebo

Other

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

Primary outcomes

  1. Cumulative incidence number of URTIs

    Time frame: Day 1 to 24 weeks

    Cumulative incidence number of Upper Respiratory Tract Infections (URTIs)

Secondary outcomes

  1. Cumulative number of infected participants

    Time frame: Day 1 to week 24

    Cumulative number of infected participants

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

    Time frame: Day 1 to week 24

    Cumulative number of days that participant recorded symptom positive to WURSS-24 (Wisconsin Upper Respiratory Symptom Survey) scoring system during intervention period.

  3. 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

    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.

  4. Length of URTI symptomatic days per one URTI episode.

    Time frame: Day 1 to week 24

    Length of Upper Respiratory Tract Infection (URTI) symptomatic days per one URTI episode.

Other outcomes

  1. Safety: Occurrence of adverse events and Serious Adverse Events

    Time frame: Day 1 to week 24

    Occurrence of adverse events and Serious Adverse Events

Sponsors and collaborators

Lead sponsor

RDC Clinical Pty Ltd

Industry

Collaborators

  • Kirin Holdings Company, Limited

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 14, 2025
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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