Clinical trial NCT06827327: LC-Plasma for Preventing URTIs and Reducing Symptoms
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Healthy Volunteer
URTI
Keywords: LC-Plasma
URTI
Healthy volunteer
Lead sponsor: RDC Clinical Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: Kirin Holdings Company, Limited
First posted: 2025-02-14
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Cumulative incidence number of URTIs
timeFrame: Day 1 to 24 weeks
Secondary outcomes:
measure: Cumulative number of infected participants
timeFrame: Day 1 to week 24
measure: Cumulative number of days that participant recorded symptom positive to WURSS-24 system
timeFrame: Day 1 to week 24
measure: Cumulative scores of each parameter in WURSS-24 scoring system, as well as the total sum of all parameters for each participant.
timeFrame: Day 1 to week 24
measure: Length of URTI symptomatic days per one URTI episode.
timeFrame: Day 1 to week 24
Other outcomes:
measure: Safety: Occurrence of adverse events and Serious Adverse Events
timeFrame: Day 1 to week 24
Locations:
city: Brisbane
country: Australia
facility: RDC Clinical
state: Queensland
Study officials:
affiliation: Kirin Holdings Company, Limited
name: Yusuke Ushida
role: STUDY_DIRECTOR
affiliation: Kirin Holdings Company, Limited
name: Osamu Kanauchi
role: STUDY_DIRECTOR
References: