LC-Plasma on Immune Response and Reducing Symptoms of Upper Respiratory Infectious Diseases

Phase 3

Not yet recruiting

• Conditions: Healthy Volunteer; Immune Response

• Registration Number: NCT06837961
• Lead Sponsor: RDC Clinical Pty Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-17
• Study First Submitted QC: 2025-02-17
• Last Update Submitted: 2025-02-19
• Study First Posted: 2025-02-20
• Last Update Posted: 2025-02-21
• Study Start: 2025-03
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 220

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The degree of activation of plasmacytoid dendritic cells (pDCs)	Week 0 to week 4	The degree of activation of plasmacytoid dendritic cells (pDCs) is measured using the indicators CD304+/CD123+, CD86+, or HLA-DR+

Secondary Outcome Measures

Name	Time	Method
Activation of Cytotoxic T Lymphocytes (CTLs)	Week 0 to week 4	The evaluation of CTLs responsible for virus elimination will be determined using the indicator (CD8+/CD3+/CD4-/IFN-γ+).
Anti-viral Activity of PBMCs	Week 0 to week 4	The anti-viral activity gene expression and IFN-α \& β production capability of PBMCs, both unstimulated and mildly stimulated with CpG, will be measured.
WURSS-24 Symptom Score	Week 0 to week 4	Symptoms will be measured using the Wisconsin Upper Respiratory Symptom Survey (WURSS-24)
Rapid antigen test (RAT)	Week 0 to week 4	Rapid antigen test (RAT) for Flu A/B, RSV \& SARS-CoV-2. Will be conducted by participants once per week, with additional tests if symptoms are present.

Trial Locations

Locations (1)

Griffith University; 🇦🇺 Southport, Queensland, Australia