Using LC-Plasma to prevent upper respiratory infections
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
PHASE3 · RDC Clinical Pty Ltd · NCT06827327
This study is testing if taking an LC-Plasma tablet every day can help healthy adults who often get colds and other upper respiratory infections stay healthier.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | RDC Clinical Pty Ltd (industry) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Brisbane, Queensland) |
| Trial ID | NCT06827327 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of LC-Plasma in preventing upper respiratory tract infections (URTIs) among healthy volunteers. Participants will take either an LC-Plasma tablet or a placebo daily for 24 weeks. The study aims to determine if LC-Plasma can significantly reduce the incidence of URTIs compared to the placebo group. By focusing on healthy adults with a history of recurrent URTIs, the research seeks to provide insights into a potential preventive treatment.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18-60 years living in Australia with a history of recurrent upper respiratory tract infections.
Not a fit: Patients with serious or unstable illnesses, or those with a BMI outside the specified range, may not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide a new preventive option for individuals prone to upper respiratory infections.
How similar studies have performed: While similar approaches have been explored, the specific use of LC-Plasma for this purpose is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Brisbane, Queensland
- RDC Clinical — Brisbane, Queensland, Australia (RECRUITING)
Study contacts
- Study coordinator: Amanda Rao
- Email: amanda@rdcglobal.com.au
- Phone: +61 (0) 414 488 559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Healthy Volunteer, URTI, LC-Plasma, Healthy volunteer