Effect of Probiotic Strain Lactobacillus Paracasei PS23 on Brain Fog in People With Long COVID

Cognitive Change Clinical Trial

— COVID-19  

Official title:

Effect of Probiotic Strain Lactobacillus Paracasei PS23 on Brain Fog in People With Long COVID

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06348212
• Other study ID #: 2022-11-008C
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Chieh Lee, Medical student
• Phone: +886-0971839369
• Email: jason.jay.lee[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• 20 to 80 year old
• had been infected by SARS-CoV-2
• Stable vital signs
• Have brain fog conplaint
• MoCA<30 at baseline

Exclusion Criteria:

• 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
• 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

Related Conditions & MeSH terms

• Cognitive Change
• Long COVID
• Mental Fatigue

Intervention

Dietary Supplement:
• Lactobacillus paracasei PS23
2 caps daily use
• microcrystalline cellulose
2 caps daily use

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long covid related symptoms	A list of symptoms related to long covid including cough, fatigue. brain fog etc.	baseline and two months after probiotic/placebo supplement
Primary	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.	baseline and two months after probiotic/placebo supplement
Primary	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.	baseline and two months after probiotic/placebo supplement
Primary	Fatigue Severity Scale	A measurement of the degree of fatigue, with score ranging from 7-49 and higher points meaning more severe fatigue.	baseline and two months after probiotic/placebo supplement
Primary	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.	baseline and two months after probiotic/placebo supplement
Primary	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.	baseline and two months after probiotic/placebo supplement
Primary	Cognitive function-The Montreal Cognitive Assessment(MoCA)	Score ranging from 0-30, with higher meaning better cognitive function	baseline and two months after probiotic/placebo supplement
Primary	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	baseline and two months after probiotic/placebo supplement
Primary	Cognitive function-Cogstate Brief Battery (CBB)	A cognitive test on ipad.	baseline and two months after probiotic/placebo supplement
Primary	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.	baseline and two months after probiotic/placebo supplement
Primary	Gut microbiota	Subjects will be asked to collect their fecal sample and the bacterial DNA/RNA will be extracted and analyzed.	baseline and two months after probiotic/placebo supplement
Primary	Fecal metabolite	Subjects will be asked to collect their fecal sample and the SCFAs in the sample will be measured.	baseline and two months after probiotic/placebo supplement