Efficacy of Lactobacillus Paracasei PS23 for Patients With Post-COVID-19 Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Clinical Global Impression scales of Severity rated by clinician（CGI）
研究概览
简要总结
To evaluate whether probiotics PS23 can improve the symptoms of patients with long COVID-19 ; also to evaluate the effects on blood cortisol and inflammation-related indicators in patients.
详细描述
It is expected that a total of 120 subjects will be recruited within 3 years after IRB approval, divided into two groups of 60 subjects, respectively consuming PS23 heat-treated bacteria or placebo, and completing the 6-week period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged above 20 years old and below 65 years old.
- •Those who consciously have long COVID-19 symptoms or actively respond to website advertisements to express interest in participating in this clinical researcher.
- •Those who received the confirmation SMS or the COVID-19 rapid test positive 4 weeks ago.
排除标准
- •Have taken antibiotics within one month or are receiving antibiotic treatment.
- •Have taken probiotic products have been used within two weeks (excluding yogurt, yogurt, Yakult and other related foods).
- •Cancer or immunocompromised patients undergoing treatment.
- •Those who are allergic to lactic acid bacteria products.
- •Diagnosed with dementia before being diagnosed with COVID-
- •Prior to or currently taking medication for acute or psychiatric illness prior to the diagnosis of COVID-
- •The investigator judges that it is not suitable to participate in the researcher.
结局指标
主要结局
Clinical Global Impression scales of Severity rated by clinician（CGI）
时间窗: From Baseline to 6 Weeks Assessed
The CGIC is a single-item questionnaire that asks the investigator to assess a patient's TD symptoms at specific visits after initiating therapy. The CGIC uses a 7 point Likert Scale, ranging from very much worse (-3) to very much improved (+3), to assess overall response to therapy. A treatment success was defined as "much improved" or "very much improved" at the week 6 visit.
次要结局
- The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16(From Baseline to 6 Weeks Assessed)
- Wechsler Adult Intelligence Scale 4th version(From Baseline to 6 Weeks Assessed)
- Insomnia Severity Index（ISI）(From Baseline to 6 Weeks Assessed)
- Color Trails Test（CTT）(From Baseline to 6 Weeks Assessed)
- Patient Heath Questionnaire-9 (PHQ-9)(From Baseline to 6 Weeks Assessed)
- State and Trait Anxiety Index (STAI)(From Baseline to 6 Weeks Assessed)
- Visual Analogue Scale-GI (VAS-GI)(From Baseline to 6 Weeks Assessed)
- Patient Global Impression scales of Improvement rated by patient（PGI-C）(From Baseline to 6 Weeks Assessed)