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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-29

Study Completion Date

2025-11-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteer Immune Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LC-Plasma

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

Group Type EXPERIMENTAL

LC-Plasma

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

1 tablet containing 50mg MCC is taken daily for 4 weeks

Interventions

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LC-Plasma

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

1 tablet containing 50mg MCC is taken daily for 4 weeks

Intervention Type OTHER

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes