LC-Plasma for Preventing URTIs and Reducing Symptoms

Phase 3

Recruiting

• Conditions: Healthy Volunteer; URTI

• Registration Number: NCT06827327
• Lead Sponsor: RDC Clinical Pty Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-10
• Study First Posted: 2025-02-14
• Study Start: 2025-03-28
• Last Update Submitted: 2025-06-22
• Last Update Posted: 2025-06-24
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 650

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cumulative incidence number of URTIs	Day 1 to 24 weeks	Cumulative incidence number of Upper Respiratory Tract Infections (URTIs)

Secondary Outcome Measures

Name	Time	Method
Cumulative number of infected participants	Day 1 to week 24	Cumulative number of infected participants
Cumulative number of days that participant recorded symptom positive to WURSS-24 system	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.
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	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.
Length of URTI symptomatic days per one URTI episode.	Day 1 to week 24	Length of Upper Respiratory Tract Infection (URTI) symptomatic days per one URTI episode.

Trial Locations

Locations (1)

RDC Clinical; 🇦🇺 Brisbane, Queensland, Australia