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

NCT06348212 | Not Yet Recruiting

• 1 other identifier: 2022-11-008C
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Long COVID; Brain Fog; Cognitive Change

Keywords

Probiotics; EEG; Gut brain axis

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (2)

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

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

Dietary Supplement: microcrystalline cellulose

Interventions

Lactobacillus paracasei PS23 DIETARY_SUPPLEMENT

2 caps daily use

Probiotic group

microcrystalline cellulose DIETARY_SUPPLEMENT

2 caps daily use

Placebo group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Mental Fatigue

Interventions

microcrystalline cellulose

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; Fatigue; Signs and Symptoms; Behavioral Symptoms; Behavior

Central Study Contacts

Chieh Lee, Medical student

CONTACT

+886-0971839369; jason.jay.lee@gmail.com

Ching-Liang Lu, MD, PhD

CONTACT

0971839369; cllu@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization were performed by the provider of probiotic and placebo. The participant will never know their group. The study Investigator and Outcome assessor will not know the groups of participants until they finish recruiting and data processing.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of endoscopy center

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 4, 2024
• Study Start: April 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share