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

NCT05813899 | Terminated

• 1 other identifier: 22CT054be
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-COVID-19 Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Wechsler Adult Intelligence Scale 4th version

  From Baseline to 6 Weeks Assessed

• Color Trails Test（CTT）

  From Baseline to 6 Weeks Assessed

• Insomnia Severity Index（ISI）

  From Baseline to 6 Weeks Assessed

• The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16

  From Baseline to 6 Weeks Assessed

• State and Trait Anxiety Index (STAI)

  From Baseline to 6 Weeks Assessed

Study Arms (2)

Heat-treated PS23

EXPERIMENTAL

PS23 heat-treated, 2 caps daily use

Dietary Supplement: PS23 heat-treated

Placebo

PLACEBO COMPARATOR

The placebo , 2 caps daily use

Dietary Supplement: PS23 heat-treated

Interventions

PS23 heat-treated DIETARY_SUPPLEMENT

PS23 heat-treated, 2 caps daily use

Heat-treated PS23; Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mackay Memorial Hospital: lead
• Bened Biomedical Co., Ltd.: collaborator

Study Sites (1)

Mackay Memorial Hospital

Taipei, 10448, Taiwan

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 14, 2023
• Study Start: January 16, 2023
• Primary Completion: December 31, 2023
• Study Completion: April 30, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Locations

TW (1)