Effect of Probiotic Strain Lactobacillus Paracasei PS23 on Brain Fog in People With Long COVID
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- GI symptoms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •20 to 80 year old
- •had been infected by SARS-CoV-2
- •Stable vital signs
- •Have brain fog conplaint
- •MoCA<30 at baseline
排除标准
- •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
研究组 & 干预措施
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
干预措施: Lactobacillus paracasei PS23 (Dietary Supplement)
Placebo group
They are given probiotic capsules of microcrystalline cellulose. Subjects should take two capsules per day for two months
干预措施: microcrystalline cellulose (Dietary Supplement)
结局指标
主要结局
GI symptoms
时间窗: baseline and two months after probiotic/placebo supplement
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.
Cognitive function-Color Trails making Test
时间窗: baseline and two months after probiotic/placebo supplement
The test is composed of two parts, easy and hard. The time taken to finish the two parts are recorded
The Pittsburgh sleep quality index
时间窗: baseline and two months after probiotic/placebo supplement
A measurement of the degree of sleep disturbance/disorder. The score ranges from 0-21, with higher points meaning more severe sleep problem.
Gut microbiota
时间窗: baseline and two months after probiotic/placebo supplement
Subjects will be asked to collect their fecal sample and the bacterial DNA/RNA will be extracted and analyzed.
Long covid related symptoms
时间窗: baseline and two months after probiotic/placebo supplement
A list of symptoms related to long covid including cough, fatigue. brain fog etc.
Fatigue Severity Scale
时间窗: baseline and two months after probiotic/placebo supplement
A measurement of the degree of fatigue, with score ranging from 7-49 and higher points meaning more severe fatigue.
Cognitive function-Digit symbol substitution test
时间窗: baseline and two months after probiotic/placebo supplement
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.
Cognitive function-The Montreal Cognitive Assessment(MoCA)
时间窗: baseline and two months after probiotic/placebo supplement
Score ranging from 0-30, with higher meaning better cognitive function
Cognitive function-Cogstate Brief Battery (CBB)
时间窗: baseline and two months after probiotic/placebo supplement
A cognitive test on ipad.
Hospital Anxiety and Depression Scale
时间窗: baseline and two months after probiotic/placebo supplement
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.
EEG
时间窗: baseline and two months after probiotic/placebo supplement
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.
Fecal metabolite
时间窗: baseline and two months after probiotic/placebo supplement
Subjects will be asked to collect their fecal sample and the SCFAs in the sample will be measured.
次要结局
未报告次要终点
研究者
Ching-Liang Lu
director of endoscopy center
Taipei Veterans General Hospital, Taiwan