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

NCT ID: NCT05813899

Last Updated: 2024-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-16

Study Completion Date

2024-04-30

Brief Summary

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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

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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

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Post-COVID-19 Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Heat-treated PS23

PS23 heat-treated, 2 caps daily use

Group Type EXPERIMENTAL

PS23 heat-treated

Intervention Type DIETARY_SUPPLEMENT

PS23 heat-treated, 2 caps daily use

Placebo

The placebo , 2 caps daily use

Group Type PLACEBO_COMPARATOR

PS23 heat-treated

Intervention Type DIETARY_SUPPLEMENT

PS23 heat-treated, 2 caps daily use

Interventions

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PS23 heat-treated

PS23 heat-treated, 2 caps daily use

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bened Biomedical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Mackay Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mackay Memorial Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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22CT054be

Identifier Type: -

Identifier Source: org_study_id

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