Efficacy of Lactobacillus Paracasei PS23 for Patients With Post-COVID-19 Syndrome
- Conditions
- Post-COVID-19 Syndrome
- Interventions
- Dietary Supplement: PS23 heat-treated
- Registration Number
- NCT05813899
- Lead Sponsor
- Mackay Memorial Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 39
- 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.
- 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-19.
- Prior to or currently taking medication for acute or psychiatric illness prior to the diagnosis of COVID-19.
- The investigator judges that it is not suitable to participate in the researcher.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Heat-treated PS23 PS23 heat-treated PS23 heat-treated, 2 caps daily use Placebo PS23 heat-treated The placebo , 2 caps daily use
- Primary Outcome Measures
Name Time Method Clinical Global Impression scales of Severity rated by clinician（CGI） 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.
- Secondary Outcome Measures
Name Time Method The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16 From Baseline to 6 Weeks Assessed The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16 (QLESQ-16) is a valid, reliable self-report instrument for assessing quality of life.
Wechsler Adult Intelligence Scale 4th version From Baseline to 6 Weeks Assessed The WAIS-IV is a measure of cognitive function in older adolescents and adults. Participants complete the Digit Span subtest, which measures auditory working memory for numerical information.
Insomnia Severity Index（ISI） From Baseline to 6 Weeks Assessed The Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia.
Color Trails Test（CTT） From Baseline to 6 Weeks Assessed There are two subtests: CTT1 \& CTT2. The time spend to complete the two subtest is used representing executive function of the participants.
Patient Heath Questionnaire-9 (PHQ-9) From Baseline to 6 Weeks Assessed The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression: The PHQ-9 incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool.Depression Severity: 0- none, 1-4 minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against an independent structured mental health professional (MHP) interview. PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression.
State and Trait Anxiety Index (STAI) From Baseline to 6 Weeks Assessed The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
Visual Analogue Scale-GI (VAS-GI) From Baseline to 6 Weeks Assessed Visual Analogue Scale for GI symptoms, VAS-GI (visual analogue scale, VAS 0-10) was designed to measure the response of symptoms and well-being in patients after taking probiotics or placebo.
Patient Global Impression scales of Improvement rated by patient（PGI-C） From Baseline to 6 Weeks Assessed The PGIC consists of one item taken from the clinical global impression and adapted to the patient. The minimum total score possible is 1 and the maximum total score possible is 7. Higher values represent a worse outcome.
Trial Locations
- Locations (1)
Mackay Memorial Hospital
🇨🇳Taipei, Taiwan