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The covid-19 epidemic was calming down and not many people were suffering from the post covid 19 syndrome
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| Name | Class |
|---|---|
| Bened Biomedical Co., Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heat-treated PS23 | Experimental | PS23 heat-treated, 2 caps daily use |
|
| Placebo | Placebo Comparator | The placebo , 2 caps daily use |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PS23 heat-treated | Dietary Supplement | PS23 heat-treated, 2 caps daily use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression scales of Severity rated by clinician（CGI） | 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. | From Baseline to 6 Weeks Assessed |
| Measure | Description | Time Frame |
|---|---|---|
| Wechsler Adult Intelligence Scale 4th version | 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. | From Baseline to 6 Weeks Assessed |
| Color Trails Test（CTT） |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mackay Memorial Hospital | Taipei | 10448 | Taiwan |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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There are two subtests: CTT1 & CTT2. The time spend to complete the two subtest is used representing executive function of the participants. |
| From Baseline to 6 Weeks Assessed |
| Insomnia Severity Index（ISI） | The Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia. | From Baseline to 6 Weeks Assessed |
| The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16 | The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16 (QLESQ-16) is a valid, reliable self-report instrument for assessing quality of life. | From Baseline to 6 Weeks Assessed |
| State and Trait Anxiety Index (STAI) | 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. | From Baseline to 6 Weeks Assessed |
| Patient Heath Questionnaire-9 (PHQ-9) | 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. | From Baseline to 6 Weeks Assessed |
| Visual Analogue Scale-GI (VAS-GI) | 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. | From Baseline to 6 Weeks Assessed |
| Patient Global Impression scales of Improvement rated by patient（PGI-C） | 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. | From Baseline to 6 Weeks Assessed |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |