Efficacy of Lactobacillus Paracasei PS23 for Patients With Post-COVID-19 Syndrome
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Heat-treated PS23 PS23 heat-treated, 2 caps daily use |
Dietary Supplement: PS23 heat-treated
PS23 heat-treated, 2 caps daily use
|
| Placebo Comparator: Placebo The placebo , 2 caps daily use |
Dietary Supplement: PS23 heat-treated
PS23 heat-treated, 2 caps daily use
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Aged above 20 years old and below 65 years old.
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Those who consciously have long COVID-19 symptoms or actively respond to website advertisements to express interest in participating in this clinical researcher.
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Those who received the confirmation SMS or the COVID-19 rapid test positive 4 weeks ago.
Exclusion Criteria:
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Have taken antibiotics within one month or are receiving antibiotic treatment.
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Have taken probiotic products have been used within two weeks (excluding yogurt, yogurt, Yakult and other related foods).
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Cancer or immunocompromised patients undergoing treatment.
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Those who are allergic to lactic acid bacteria products.
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Diagnosed with dementia before being diagnosed with COVID-19.
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Prior to or currently taking medication for acute or psychiatric illness prior to the diagnosis of COVID-19.
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The investigator judges that it is not suitable to participate in the researcher.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mackay Memorial Hospital | Taipei | Taiwan | 10448 |
Sponsors and Collaborators
- Mackay Memorial Hospital
- Bened Biomedical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22CT054be