An interventional study of PS23 heat-treated in Post-COVID-19 Syndrome, sponsored by Mackay Memorial Hospital. Terminated at 1 site in Taiwan. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-15.
Sponsored by Mackay Memorial Hospital · Not applicable, Interventional, and Supportive care
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.
7,641 studies on the registry are indexed under COVID-19; 487 are open to participants now.
This study's enrollment of 39 is below the median of 100 across 4,100 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Mackay Memorial Hospital is the lead sponsor of 118 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
PS23 heat-treated, 2 caps daily use
Dietary Supplement: PS23 heat-treated
The placebo , 2 caps daily use
Dietary Supplement: PS23 heat-treated
PS23 heat-treated, 2 caps daily use
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.
Time frame: From Baseline to 6 Weeks Assessed
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.
Time frame: From Baseline to 6 Weeks Assessed
Color Trails Test（CTT）
There are two subtests: CTT1 \& CTT2. The time spend to complete the two subtest is used representing executive function of the participants.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Baseline to 6 Weeks Assessed
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Mackay Memorial Hospital