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

NCT ID: NCT06348212

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2025-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

Lactobacillus paracasei PS23

Intervention Type: DIETARY_SUPPLEMENT

2 caps daily use

Placebo group

They are given probiotic capsules of microcrystalline cellulose. Subjects should take two capsules per day for two months

Group Type: PLACEBO_COMPARATOR

microcrystalline cellulose

Intervention Type: DIETARY_SUPPLEMENT

2 caps daily use

Interventions

Lactobacillus paracasei PS23

2 caps daily use

Intervention Type: DIETARY_SUPPLEMENT

microcrystalline cellulose

2 caps daily use

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ching-Liang Lu

director of endoscopy center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Chieh Lee, Medical student

Role: CONTACT

jason.jay.lee@gmail.com

+886-0971839369

Ching-Liang Lu, MD, PhD

Role: CONTACT

cllu@vghtpe.gov.tw

0971839369

Other Identifiers

2022-11-008C

Identifier Type: -

Identifier Source: org_study_id