Back to resultsEfficacy of Lactobacillus Paracasei PS23 for Patients With Post-COVID-19 Syndrome
Primary Purpose
Post-COVID-19 Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
PS23 heat-treated
Sponsored by
About this trial
This is an interventional supportive care trial for Post-COVID-19 Syndrome
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Mackay Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Heat-treated PS23
Placebo
Arm Description
PS23 heat-treated, 2 caps daily use
The placebo , 2 caps daily use
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05813899
First Posted
April 11, 2023
Last Updated
July 14, 2023
Sponsor
Mackay Memorial Hospital
Collaborators
Bened Biomedical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05813899
Brief Title
Efficacy of Lactobacillus Paracasei PS23 for Patients With Post-COVID-19 Syndrome
Official Title
Efficacy of Lactobacillus Paracasei PS23 for Patients With Post-COVID-19 Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2023 (Actual)
Primary Completion Date
January 15, 2026 (Anticipated)
Study Completion Date
January 15, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mackay Memorial Hospital
Collaborators
Bened Biomedical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-COVID-19 Syndrome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Heat-treated PS23
Arm Type
Experimental
Arm Description
PS23 heat-treated, 2 caps daily use
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo , 2 caps daily use
Intervention Type
Dietary Supplement
Intervention Name(s)
PS23 heat-treated
Intervention Description
PS23 heat-treated, 2 caps daily use
Primary Outcome Measure Information:
Title
Clinical Global Impression scales of Severity rated by clinician（CGI）
Description
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
Secondary Outcome Measure Information:
Title
Wechsler Adult Intelligence Scale 4th version
Description
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
Title
Color Trails Test（CTT）
Description
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
Title
Insomnia Severity Index（ISI）
Description
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
Title
The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16
Description
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
Title
State and Trait Anxiety Index (STAI)
Description
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
Title
Patient Heath Questionnaire-9 (PHQ-9)
Description
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
Title
Visual Analogue Scale-GI (VAS-GI)
Description
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
Title
Patient Global Impression scales of Improvement rated by patient（PGI-C）
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
10448
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu-I Wu, Ph.D
Phone
0975835215
Email
shuiwu@g.ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Wan-Lin Chen, Bacholar
Phone
0918830146
Email
fatty09222002@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy of Lactobacillus Paracasei PS23 for Patients With Post-COVID-19 Syndrome
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