NCT06837961已完成3 期
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.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 241
- 试验地点
- 2
- 主要终点
- The degree of activation of plasmacytoid dendritic cells (pDCs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
The degree of activation of plasmacytoid dendritic cells (pDCs)
时间窗: 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+
次要结局
- Activation of Cytotoxic T Lymphocytes (CTLs)(Week 0 to week 4)
- Anti-viral Activity of PBMCs(Week 0 to week 4)
- WURSS-24 Symptom Score(Week 0 to week 4)
- Rapid antigen test (RAT)(Week 0 to week 4)
研究者
研究点 (2)
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