Clinical trial NCT06348212: Effect of Probiotic Strain Lactobacillus Paracasei PS23 on Brain Fog in People With Long COVID
Official title: Effect of Probiotic Strain Lactobacillus Paracasei PS23 on Brain Fog in People With Long COVID
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Long COVID
Brain Fog
Cognitive Change
Keywords: Probiotics
EEG
Gut brain axis
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2024-04-04
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Long covid related symptoms
timeFrame: baseline and two months after probiotic/placebo supplement
measure: Hospital Anxiety and Depression Scale
timeFrame: baseline and two months after probiotic/placebo supplement
measure: The Pittsburgh sleep quality index
timeFrame: baseline and two months after probiotic/placebo supplement
measure: Fatigue Severity Scale
timeFrame: baseline and two months after probiotic/placebo supplement
measure: GI symptoms
timeFrame: baseline and two months after probiotic/placebo supplement
measure: Cognitive function-Digit symbol substitution test
timeFrame: baseline and two months after probiotic/placebo supplement
measure: Cognitive function-The Montreal Cognitive Assessment(MoCA)
timeFrame: baseline and two months after probiotic/placebo supplement
measure: Cognitive function-Color Trails making Test
timeFrame: baseline and two months after probiotic/placebo supplement
measure: Cognitive function-Cogstate Brief Battery (CBB)
timeFrame: baseline and two months after probiotic/placebo supplement
measure: EEG
timeFrame: baseline and two months after probiotic/placebo supplement
measure: Gut microbiota
timeFrame: baseline and two months after probiotic/placebo supplement
measure: Fecal metabolite
timeFrame: baseline and two months after probiotic/placebo supplement
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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