Post-COVID-19 SyndromeNCT05813899
Efficacy of Lactobacillus Paracasei PS23 for Patients With Post-COVID-19 Syndrome
A study testing PS23 heat-treated in people with Post-COVID-19 Syndrome, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Post-COVID-19 Syndrome
- What is being tested?
- PS23 heat-treated
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Jan 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Post-COVID-19 Syndrome
- Being tested
- PS23 heat-treated
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PS23 heat-treatedDietary supplement
PS23 heat-treated, 2 caps daily use
| Study group | Role | What they receive |
|---|---|---|
| Heat-treated PS23 | Experimental | PS23 heat-treated, 2 caps daily use Receives: Dietary Supplement: PS23 heat-treated |
| Placebo | Placebo comparator | The placebo , 2 caps daily use Receives: Dietary Supplement: PS23 heat-treated |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Baseline to 6 Weeks Assessed
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Baseline to 6 Weeks Assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start16 Jan 2023
- Primary completion31 Dec 2023
- Study completion30 Apr 2024
Why it stopped: The covid-19 epidemic was calming down and not many people were suffering from the post covid 19 syndrome
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-COVID-19 SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bened Biomedical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813899
- Sponsor's protocol ID
- 22CT054be
- Status last verified
- Aug 2024
- First submitted
- 11 Apr 2023
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lactobacillus Paracasei PS23 for Patients With Post-COVID-19 Syndrome
- ClinicalTrials.gov ID
- NCT05813899
- Acronym / sponsor ID
- 22CT054be
- Conditions
- Post-COVID-19 Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The covid-19 epidemic was calming down and not many people were suffering from the post covid 19 syndrome
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Collaborators
- Bened Biomedical Co., Ltd.
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heat-treated PS23 | Experimental | Dietary Supplement: PS23 heat-treatedPS23 heat-treated, 2 caps daily use |
| Placebo | Placebo comparator | Dietary Supplement: PS23 heat-treatedThe placebo , 2 caps daily use |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PS23 heat-treatedPS23 heat-treated, 2 caps daily use | Dietary supplement | Heat-treated PS23, Placebo |
Primary outcome
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.
8 secondary outcomes
Wechsler Adult Intelligence Scale 4th version
Time frame: From Baseline to 6 Weeks Assessed
Color Trails Test（CTT）
Time frame: From Baseline to 6 Weeks Assessed
Insomnia Severity Index（ISI）
Time frame: From Baseline to 6 Weeks Assessed
The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16
Time frame: From Baseline to 6 Weeks Assessed
State and Trait Anxiety Index (STAI)
Time frame: From Baseline to 6 Weeks Assessed
Patient Heath Questionnaire-9 (PHQ-9)
Time frame: From Baseline to 6 Weeks Assessed
Visual Analogue Scale-GI (VAS-GI)
Time frame: From Baseline to 6 Weeks Assessed
Patient Global Impression scales of Improvement rated by patient（PGI-C）
Time frame: From Baseline to 6 Weeks Assessed
Results and safety
The study was stopped early (reason given: The covid-19 epidemic was calming down and not many people were suffering from the post covid 19 syndrome). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PS23 heat-treated in people with Post-COVID-19 Syndrome, run by Mackay Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The covid-19 epidemic was calming down and not many people were suffering from the post covid 19 syndrome). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impression scales of Severity rated by clinician（CGI） (time frame: From Baseline to 6 Weeks Assessed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.