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

RDC Clinical

Status and phase: Completed; Phase 3

Conditions: Immune Response; Healthy Volunteer

Treatments: Dietary Supplement: LC-Plasma; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06837961

GU/2025/073

Details and patient eligibility

About

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.

Enrollment: 241 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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241 participants in 2 patient groups, including a placebo group

LC-Plasma

Experimental group

Description:

1 tablet containing 50mg LC-Plasma is taken daily for 4 weeks

Treatment:

Dietary Supplement: LC-Plasma

Placebo

Placebo Comparator group

Description:

1 tablet containing 50mg microcrystalline cellulose is taken daily for 4 weeks

Treatment:

Other: Placebo