Long COVIDCOVID-19NCT06348212
Effect of Probiotic Strain Lactobacillus Paracasei PS23 on Brain Fog in People With Long COVID
A study testing Lactobacillus paracasei PS23 and microcrystalline cellulose in people with Long COVID and Brain Fog, run by Taipei Veterans General Hospital, Taiwan.
Trial summary
The goal of this clinical trial is to test whether the intervention of probiotics supplement can improve symptoms of long covid syndrome. Participants will be given probiotics or placebo capsules for two month. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Long COVID, Brain Fog, Cognitive Change
- What is being tested?
- Lactobacillus paracasei PS23 and microcrystalline cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Dec 2025
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 20 to 80 year old
- had been infected by SARS-CoV-2
- Stable vital signs
- Have brain fog conplaint
- MoCA<30 at baseline
Who cannot join
- refuse to join the study or refuse to sign the Informed Consent Form
- have other neurological disease that may affect cognitive function, such as Parkinson disease, Seizure, etc.
- have other gastrointestinal disease that may affect cognitive function, including tumors.
- severe hearing loss or visual loss that may hinder cognitive function tests
- Taken anti-seizure drug in 7 days.
- Already taking probiotics supplement regularly
Show all 15Show fewer
- Taken antibiotics in two weeks
- taking stool softener or laxative regularly
- have valvular heart disease
- have congenital or acquired immunodeficiency or is under iimmunosuppressant therapy
- Pregnant or plans to be pregnant
- BMI>30
- Have been performed severe gastrointestinal surgery(s)
- Severe liver, kidney, cardiovascular, hematologic or metabolic disorder
- In critical condition
Trial locations and contacts
No sites are listed yet.
About this study
The goal of this clinical trial is to test whether the intervention of probiotics supplement can improve symptoms of long covid syndrome.
Participants will be given probiotics or placebo capsules for two month. Symptom questionnaires, cognitive function, eeg and fecal sample are recorded/collected before and after the supplement.
Researchers will compare the probiotic group and the placebo to see if probiotic supplement really make differences.
Read the detailed description
After the pandemic of covid-19, people found out that not only does it cause acute respiratory system symptoms, but it also affect many other systems even long after the acute symptoms have resolved, which is named the Long Covid Syndrome. Studies have shown that the gut microbiota of those suffering from long covid syndrome differ from that of healthy people and those who recovered from covid without getting long covid syndrome, which implied the possibility of probiotic supplement being an effective treatment to long covid. This double-blind parallel randomized control trail plans to supply participants with probiotics or placebo fortwo months. Symptom questionnaires, cognitive function, eeg and fecal sample will be recorded/collected before and after the supplement. Researchers will compare the two groups to see if they differ in the above measure and to see if the differences in symptoms and cognitive functions change correlate with gut microbiota change and fecal metabolite change.
- Conditions
- Long COVID, Brain Fog, Cognitive Change
- Being tested
- Lactobacillus paracasei PS23, microcrystalline cellulose
- Keywords
- Probiotics, EEG, Gut brain axis
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus paracasei PS23Dietary supplement
2 caps daily use
microcrystalline celluloseDietary supplement
2 caps daily use
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | They are given probiotic capsules of Lactobacillus paracasei PS23. Each capsule contains 100 mg of probiotic powder(10,000,000,000 CFU) Subjects should take two capsules per day for two months Receives: Dietary Supplement: Lactobacillus paracasei PS23 |
| Placebo group | Placebo comparator | They are given probiotic capsules of microcrystalline cellulose. Subjects should take two capsules per day for two months Receives: Dietary Supplement: microcrystalline cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long covid related symptoms
A list of symptoms related to long covid including cough, fatigue. brain fog etc.
Measured: baseline and two months after probiotic/placebo supplement
Hospital Anxiety and Depression Scale
A measurement of the degree of depression and anxiety, with 7 questions each and 0-3 points for each question. Two scores ranging from 0-21 will be calculated, with higher points meaning more severe depression or anxiety.
Measured: baseline and two months after probiotic/placebo supplement
The Pittsburgh sleep quality index
A measurement of the degree of sleep disturbance/disorder. The score ranges from 0-21, with higher points meaning more severe sleep problem.
Measured: baseline and two months after probiotic/placebo supplement
Fatigue Severity Scale
A measurement of the degree of fatigue, with score ranging from 7-49 and higher points meaning more severe fatigue.
Measured: baseline and two months after probiotic/placebo supplement
GI symptoms
Rome Criteria Questionnaire in functional UGI disease and Rome Criteria Questionnaire in IBS are included in the questionnaire are measured to see if probiotic/placebo supplement results in adverse gi events or a change of bowel habits.
Measured: baseline and two months after probiotic/placebo supplement
Cognitive function-Digit symbol substitution test
a list of paired numbers and symbols are given to participants, and they are ask to match symbols to numbers accordingly. The number of question they answer within 90 second will be recorded.
Measured: baseline and two months after probiotic/placebo supplement
Cognitive function-The Montreal Cognitive Assessment(MoCA)
Score ranging from 0-30, with higher meaning better cognitive function
Measured: baseline and two months after probiotic/placebo supplement
Cognitive function-Color Trails making Test
The test is composed of two parts, easy and hard. The time taken to finish the two parts are recorded
Measured: baseline and two months after probiotic/placebo supplement
Cognitive function-Cogstate Brief Battery (CBB)
A cognitive test on ipad.
Measured: baseline and two months after probiotic/placebo supplement
EEG
2 minutes of resting-state eye-open eeg were recored. After a brief rest, a working memory task will be repeated for 12 times.
In the task, subjects will be shown balls in a 5*5 chart, the location of which They are asked to remember. 6 second later, they are shown another ball, and they will be asked if the location of the newly shown ball are identical with any of the originally shown balls.
Measured: baseline and two months after probiotic/placebo supplement
Gut microbiota
Subjects will be asked to collect their fecal sample and the bacterial DNA/RNA will be extracted and analyzed.
Measured: baseline and two months after probiotic/placebo supplement
Fecal metabolite
Subjects will be asked to collect their fecal sample and the SCFAs in the sample will be measured.
Measured: baseline and two months after probiotic/placebo supplement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ching-Liang Lu, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348212
- Sponsor's protocol ID
- 2022-11-008C
- Acronym
- COVID-19
- Status last verified
- Apr 2024
- First submitted
- 18 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic Strain Lactobacillus Paracasei PS23 on Brain Fog in People With Long COVID
- ClinicalTrials.gov ID
- NCT06348212
- Acronym / sponsor ID
- COVID-19 / 2022-11-008C
- Conditions
- Long COVID, Brain Fog, Cognitive Change
- Keywords
- Probiotics, EEG, Gut brain axis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Apr 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 Apr 2024 (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.
The goal of this clinical trial is to test whether the intervention of probiotics supplement can improve symptoms of long covid syndrome.
Participants will be given probiotics or placebo capsules for two month. Symptom questionnaires, cognitive function, eeg and fecal sample are recorded/collected before and after the supplement.
Researchers will compare the probiotic group and the placebo to see if probiotic supplement really make differences.
Detailed description
After the pandemic of covid-19, people found out that not only does it cause acute respiratory system symptoms, but it also affect many other systems even long after the acute symptoms have resolved, which is named the Long Covid Syndrome. Studies have shown that the gut microbiota of those suffering from long covid syndrome differ from that of healthy people and those who recovered from covid without getting long covid syndrome, which implied the possibility of probiotic supplement being an effective treatment to long covid. This double-blind parallel randomized control trail plans to supply participants with probiotics or placebo fortwo months. Symptom questionnaires, cognitive function, eeg and fecal sample will be recorded/collected before and after the supplement. Researchers will compare the two groups to see if they differ in the above measure and to see if the differences in symptoms and cognitive functions change correlate with gut microbiota change and fecal metabolite change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: Lactobacillus paracasei PS23They are given probiotic capsules of Lactobacillus paracasei PS23. Each capsule contains 100 mg of probiotic powder(10,000,000,000 CFU) Subjects should take two capsules per day for two months |
| Placebo group | Placebo comparator | Dietary Supplement: microcrystalline celluloseThey are given probiotic capsules of microcrystalline cellulose. Subjects should take two capsules per day for two months |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 20 to 80 year old
- had been infected by SARS-CoV-2
- Stable vital signs
- Have brain fog conplaint
- MoCA<30 at baseline
Key exclusion criteria (15 listed)
- refuse to join the study or refuse to sign the Informed Consent Form
- have other neurological disease that may affect cognitive function, such as Parkinson disease, Seizure, etc.
- have other gastrointestinal disease that may affect cognitive function, including tumors.
- severe hearing loss or visual loss that may hinder cognitive function tests
- Taken anti-seizure drug in 7 days.
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 |
|---|---|---|
| Lactobacillus paracasei PS232 caps daily use | Dietary supplement | Probiotic group |
| microcrystalline cellulose2 caps daily use | Dietary supplement | Placebo group |
Primary outcome
Long covid related symptoms
Time frame: baseline and two months after probiotic/placebo supplement
A list of symptoms related to long covid including cough, fatigue. brain fog etc.
Hospital Anxiety and Depression Scale
Time frame: baseline and two months after probiotic/placebo supplement
A measurement of the degree of depression and anxiety, with 7 questions each and 0-3 points for each question. Two scores ranging from 0-21 will be calculated, with higher points meaning more severe depression or anxiety.
The Pittsburgh sleep quality index
Time frame: baseline and two months after probiotic/placebo supplement
A measurement of the degree of sleep disturbance/disorder. The score ranges from 0-21, with higher points meaning more severe sleep problem.
Fatigue Severity Scale
Time frame: baseline and two months after probiotic/placebo supplement
A measurement of the degree of fatigue, with score ranging from 7-49 and higher points meaning more severe fatigue.
GI symptoms
Time frame: baseline and two months after probiotic/placebo supplement
Rome Criteria Questionnaire in functional UGI disease and Rome Criteria Questionnaire in IBS are included in the questionnaire are measured to see if probiotic/placebo supplement results in adverse gi events or a change of bowel habits.
Cognitive function-Digit symbol substitution test
Time frame: baseline and two months after probiotic/placebo supplement
a list of paired numbers and symbols are given to participants, and they are ask to match symbols to numbers accordingly. The number of question they answer within 90 second will be recorded.
Cognitive function-The Montreal Cognitive Assessment(MoCA)
Time frame: baseline and two months after probiotic/placebo supplement
Score ranging from 0-30, with higher meaning better cognitive function
Cognitive function-Color Trails making Test
Time frame: baseline and two months after probiotic/placebo supplement
The test is composed of two parts, easy and hard. The time taken to finish the two parts are recorded
Cognitive function-Cogstate Brief Battery (CBB)
Time frame: baseline and two months after probiotic/placebo supplement
A cognitive test on ipad.
EEG
Time frame: baseline and two months after probiotic/placebo supplement
2 minutes of resting-state eye-open eeg were recored. After a brief rest, a working memory task will be repeated for 12 times. In the task, subjects will be shown balls in a 5*5 chart, the location of which They are asked to remember. 6 second later, they are shown another ball, and they will be asked if the location of the newly shown ball are identical with any of the originally shown balls.
Gut microbiota
Time frame: baseline and two months after probiotic/placebo supplement
Subjects will be asked to collect their fecal sample and the bacterial DNA/RNA will be extracted and analyzed.
Fecal metabolite
Time frame: baseline and two months after probiotic/placebo supplement
Subjects will be asked to collect their fecal sample and the SCFAs in the sample will be measured.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Long COVID
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Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus paracasei PS23 and microcrystalline cellulose in people with Long COVID and Brain Fog, run by Taipei Veterans General Hospital, 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 5 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chieh Lee, Medical student (+886-0971839369, jason.jay.lee@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long covid related symptoms (time frame: baseline and two months after probiotic/placebo supplement). The study lists 12 primary outcomes in all. 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 4 Apr 2024.