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

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.

Study Overview

• Status: Terminated
• Conditions: Post-COVID-19 Syndrome
• Intervention / Treatment: Dietary supplement: PS23 heat-treated

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 10448
    • Mackay Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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）	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
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

Collaborators and Investigators

• Sponsor: Mackay Memorial Hospital
• Collaborators: Bened Biomedical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease; COVID-19; Syndrome
• Other Study ID Numbers: 22CT054be

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No