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Search / Trial NCT06837961

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

Launched by RDC CLINICAL PTY LTD · Feb 17, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Lc Plasma Healthy Volunteer

ClinConnect Summary

This clinical trial is studying the effects of a product called LC-Plasma on the immune system and its ability to reduce symptoms of upper respiratory infections, such as the common cold. The researchers want to see how well LC-Plasma helps the body fight off viruses by looking at immune response and whether it can make symptoms less severe. Healthy adults aged 18 to 60 who have received at least two doses of a COVID-19 vaccine may be eligible to participate. They should not have any significant health issues or respiratory infections at the time of joining the study.

Participants will take either a daily tablet containing LC-Plasma or a placebo (which looks like the active treatment but has no effect) for four weeks. Throughout the study, they will need to keep track of their health, provide blood and urine samples, and follow some guidelines regarding medication and lifestyle. This study is not yet recruiting participants, but it aims to gather important information that could help improve treatments for respiratory infections in the future.

Gender

ALL

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).

About Rdc Clinical Pty Ltd

RDC Clinical Pty Ltd is a leading clinical research organization dedicated to advancing medical science through innovative trial design and execution. With a strong focus on delivering high-quality data and patient-centered research solutions, RDC Clinical partners with pharmaceutical, biotechnology, and medical device companies to facilitate the development of new therapies. Their team of experienced professionals is committed to maintaining the highest ethical standards and regulatory compliance, ensuring the integrity of clinical trials while optimizing operational efficiencies. RDC Clinical's expertise spans various therapeutic areas, making them a trusted partner in the clinical development landscape.

Locations

Southport, Queensland, Australia

Patients applied

0 patients applied

Trial Officials

Yusuke Ushida

Study Director

Kirin Holdings Company, Limited

Osamu Kanauchi

Study Director

Kirin Holdings Company, Limited

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported