Clinical trial NCT06837961: LC-Plasma on Immune Response and Reducing Symptoms of Upper Respiratory Infectious Diseases
Official title: The Effects of Lactococcus Lactis JCM 5805 (LC-Plasma) Lactic Acid Bacteria on Immune Response and Reducing Symptoms of Upper Respiratory Infectious Disease in Australian Healthy Adults. Randomized Placebo-controlled Double-blind Parallel Group Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Healthy Volunteer
Immune Response
Keywords: LC-Plasma
Healthy volunteer
Lead sponsor: RDC Clinical Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: Kirin Holdings Company, Limited
First posted: 2025-02-20
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to evaluate the effects of LC-Plasma on the innate and acquired immune systems, including the activation of pDCs, which play a role in virus elimination, as well as to assess its efficacy in reducing clinical symptoms of upper respiratory infectious diseases in healthy adults. Researchers will compare LC-Plasma to placebo, participants will take a tablet containing LC-Plasma or placebo daily for 4 weeks.


Eligibility criteria: Inclusion Criteria:

* Individuals who can provide a signed and dated informed consent form after confirming their willingness to participate.
* Individuals willing to comply with all study procedures during the study period, including daily monitoring record compliance, cooperating with blood and urine sample collection and performing regular RATs.
* Healthy people living in Australia aged 18-60 (both men and women).
* Individuals who have received at least two doses of a SARS-CoV-2 vaccine, with at least two weeks having passed since the last dose.
* Individuals who are not currently infected with SARS-CoV-2 and, if previously infected, have recovered and have been infection-free for at least four weeks.
* Individuals who do not have any chronic or acute illnesses, including respiratory and/or gastrointestinal and/or other diseases, (e.g. hypertension, IBS, IBD, SLE, cancer, asthma, primary or secondary immunodeficiencies etc.), at the time of enrolment.

Exclusion Criteria:

* Individuals medically prescribed medications that would affect the immune and/or the inflammatory response.
* Individuals deemed unsuitable for participation by Griffith CTU staff and/or the study clinician.
* Active smokers/vapers and/or individuals with nicotine or drug habits.
* Individuals currently participating in (or planning to participate in) other clinical trials.
* Women who are pregnant, planning to become pregnant during the study period, or are currently breastfeeding.
* Individuals unable to abstain from alcohol for two days prior to blood and urine sample collection.
* Individuals unable to refrain from consuming other lactic acid bacteria supplements.
* Individuals who are known to be HIV, HTLV-1, or HCV positive (based on answers to the enrolment questionnaire).

Primary outcomes:
measure: The degree of activation of plasmacytoid dendritic cells (pDCs)
timeFrame: Week 0 to week 4
Secondary outcomes:
measure: Activation of Cytotoxic T Lymphocytes (CTLs)
timeFrame: Week 0 to week 4
measure: Anti-viral Activity of PBMCs
timeFrame: Week 0 to week 4
measure: WURSS-24 Symptom Score
timeFrame: Week 0 to week 4
measure: Rapid antigen test (RAT)
timeFrame: Week 0 to week 4
Other outcomes:
measure: Safety: Occurrence of adverse events
timeFrame: Week 0 to week 4
measure: Safety: Confirmation of medical history during study period
timeFrame: Week 0 to week 4
Locations:
city: Southport
country: Australia
facility: Griffith University
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: