Effect of Probiotic Strain Lactobacillus Paracasei PS23 on Brain Fog in People With Long COVID (COVID-19)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cognitive Change; Long COVID; Brain Fog
• Intervention / Treatment: Dietary supplement: Lactobacillus paracasei PS23; Dietary supplement: microcrystalline cellulose

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chieh Lee, Medical student; Phone Number: +886-0971839369; Email: jason.jay.lee@gmail.com
• Study Contact Backup: Name: Ching-Liang Lu, MD, PhD; Phone Number: 0971839369; Email: cllu@vghtpe.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic group; 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	Dietary supplement: Lactobacillus paracasei PS23; 2 caps daily use
Placebo Comparator: Placebo group; They are given probiotic capsules of microcrystalline cellulose. Subjects should take two capsules per day for two months	Dietary supplement: microcrystalline cellulose; 2 caps daily use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
Cognitive function-Cogstate Brief Battery (CBB)	A cognitive test on ipad.	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.	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.	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.	baseline and two months after probiotic/placebo supplement

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Probiotics; EEG; Gut brain axis
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Fatigue; Chronic Disease; Post-Infectious Disorders; COVID-19; Mental Fatigue; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: 2022-11-008C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No