The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Lactobacillus Paracasei PS23 for Patients With Post-COVID-19 Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05813899
Recruitment Status : Recruiting
First Posted : April 14, 2023
Last Update Posted : July 17, 2023
Sponsor:
Collaborator:
Bened Biomedical Co., Ltd.
Information provided by (Responsible Party):
Mackay Memorial Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Post-COVID-19 Syndrome Dietary Supplement: PS23 heat-treated Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Efficacy of Lactobacillus Paracasei PS23 for Patients With Post-COVID-19 Syndrome
Actual Study Start Date : January 16, 2023
Estimated Primary Completion Date : January 15, 2026
Estimated Study Completion Date : January 15, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Clinical Global Impression scales of Severity rated by clinician（CGI） [ Time Frame: 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 :
  1. Wechsler Adult Intelligence Scale 4th version [ Time Frame: 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.

  2. Color Trails Test（CTT） [ Time Frame: 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.

  3. Insomnia Severity Index（ISI） [ Time Frame: 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.

  4. The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16 [ Time Frame: 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.

  5. State and Trait Anxiety Index (STAI) [ Time Frame: 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.

  6. Patient Heath Questionnaire-9 (PHQ-9) [ Time Frame: 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.

  7. Visual Analogue Scale-GI (VAS-GI) [ Time Frame: 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.

  8. Patient Global Impression scales of Improvement rated by patient（PGI-C） [ Time Frame: 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged above 20 years old and below 65 years old.
  2. Those who consciously have long COVID-19 symptoms or actively respond to website advertisements to express interest in participating in this clinical researcher.
  3. Those who received the confirmation SMS or the COVID-19 rapid test positive 4 weeks ago.

Exclusion Criteria:

  1. Have taken antibiotics within one month or are receiving antibiotic treatment.
  2. Have taken probiotic products have been used within two weeks (excluding yogurt, yogurt, Yakult and other related foods).
  3. Cancer or immunocompromised patients undergoing treatment.
  4. Those who are allergic to lactic acid bacteria products.
  5. Diagnosed with dementia before being diagnosed with COVID-19.
  6. Prior to or currently taking medication for acute or psychiatric illness prior to the diagnosis of COVID-19.
  7. The investigator judges that it is not suitable to participate in the researcher.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05813899


Locations
Layout table for location information
Taiwan
Mackay Memorial Hospital Recruiting
Taipei, Taiwan, 10448
Contact: Shu-I Wu, Ph.D    0975835215    shuiwu@g.ntu.edu.tw   
Contact: Wan-Lin Chen, Bacholar    0918830146    fatty09222002@gmail.com   
Sponsors and Collaborators
Mackay Memorial Hospital
Bened Biomedical Co., Ltd.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT05813899    
Other Study ID Numbers: 22CT054be
First Posted: April 14, 2023    Key Record Dates
Last Update Posted: July 17, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Syndrome
Disease
Pathologic Processes
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
 Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases