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

Taipei Veterans General Hospital

Status: Not yet enrolling

Conditions: Cognitive Change; Long COVID; Brain Fog

Treatments: Dietary Supplement: Lactobacillus paracasei PS23; Dietary Supplement: microcrystalline cellulose

Study type: Interventional

Funder types: Other

Identifiers

NCT06348212

2022-11-008C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Probiotic group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Lactobacillus paracasei PS23

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: microcrystalline cellulose