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

Taipei Veterans General Hospital, Taiwan0 sites60 target enrollmentStarted: April 2024Last updated: April 4, 2024

Conditions

Trial Snapshot

Phase: Not Applicable
Status: Not yet recruiting
Sponsor: Taipei Veterans General Hospital, Taiwan
Enrollment: 60
Primary Endpoint: GI symptoms

Study Overview Study Design Eligibility Criteria Outcomes Investigators Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: Triple (Participant, Investigator, Outcomes Assessor)

Masking Description

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.

Eligibility Criteria

Ages: 20 Years to 80 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: Yes

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
•Have been performed severe gastrointestinal surgery(s)
•Severe liver, kidney, cardiovascular, hematologic or metabolic disorder
•In critical condition