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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
2 caps daily use
2 caps daily use
Long covid related symptoms
A list of symptoms related to long covid including cough, fatigue. brain fog etc.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline and two months after probiotic/placebo supplement
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Cognitive function-The Montreal Cognitive Assessment(MoCA)
Score ranging from 0-30, with higher meaning better cognitive function
Time frame: 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
Time frame: baseline and two months after probiotic/placebo supplement
Cognitive function-Cogstate Brief Battery (CBB)
A cognitive test on ipad.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline and two months after probiotic/placebo supplement