Post COVID-19 Syndrome: A Pilot Study to Explore the Gut-lung Axis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Interleukin 6
研究概览
简要总结
The outbreak of the novel coronavirus (SARS-CoV-2)-infected disease (COVID-19) began in December 2019, spread throughout China in early 2020 and developed as a pandemic thereafter.
Based on current knowledge, Covid-19 infection causes mild to moderate respiratory and gastrointestinal symptoms in the majority of patients. In a smaller percentage severe disease courses are observed, often with the need of hospitalization and intensive care treatment. Apparently, symptoms can persist for relatively long time after viral clearance, suggesting the existence of a "Post-Covid" syndrome. A study from the UK identified fatigue, breathlessness and psychosocial stress as common symptoms after discharge from the hospital. Covid-19 infection is frequently characterized by a hyperinflammatory phenotype and a cytokine storm. The Covid-19 cytokine storm is characterised by rapid proliferation and hyperactivation of T cells, macrophages, mast cells, neutrophil granulocytes and natural killer cells, and the overproduction of inflammatory cytokines and chemical mediators released by immune or nonimmune cells. Early data also suggest that even if symptoms are just 'mild to moderate' during the acute infection, fibrotic lung damage develops in some patients. This may lead to long-term pulmonary complications for a subset of patients. The mechanisms for post-Covid pulmonary fibrosis are still unclear: inflammation triggering fibrosis, epithelial and endothelial injury with inadequate fibroproliferation and vascular damage are considered to be possible mechanisms.
A potential therapeutic target in ameliorating post-Covid symptoms could be the gut microbiome. Gut microbiome alterations have been described in Covid-19. The gut-lung axis as a link between dysbiosis, barrier dysfunction, translocation of bacterial products and hyperinflammation has been proposed as a potential therapeutic target. Probiotics have been proposed to be a possible modulator of the deranged gut-lung axis in Covid-disease and post-Covid syndrome. Currently 11 studies are registered in clinicaltrials.gov for treatment of acute Covid disease and prevention of the disease (including one study from Graz), but no study related to post-Covid syndrome could be found.
Therefore, it is currently unclear, which clinical, immune system or microbiome related biomarker would be the best to study the effect of a microbiome-based intervention in post-Covid syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •Covid-19 infection with severe disease defined within the last 12 months (defined as one or more of the following: hospitalization, need for oxygen supply, need for intensive care treatment, need for specific treatment of Covid disease, antibiotic treatment)
- •Subjective presence of residual symptoms of Covid disease OR no residual symptoms of Covid disease (Controls)
- •Informed consent
排除标准
- •Continuous probiotic treatment in the last 4 weeks before inclusion
- •Pre-existing lung diseases
研究组 & 干预措施
Synbiotic
Omni-Biotic Pro Vi 5
干预措施: Omni-Biotic Pro Vi 5 (Dietary Supplement)
Placebo
similar looking and tasting
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Interleukin 6
时间窗: 6 months
Change in interleukin 6 serum levels over time and with/without the intervention
TNFalpha
时间窗: 6 months
Change in TNFalpha levels serum over time and with/without the intervention
Interleukin 6 receptor
时间窗: 6 months
Change in Interleukin 6 receptor serum levels over time and with/without the intervention
interleukin 8
时间窗: 6 months
Change in interleukin 8 serum levels over time and with/without the intervention
interleukin 10
时间窗: 6 months
Change in interleukin 10 serum levels over time and with/without the intervention
monocyte phagocytosis
时间窗: 6 months
Change in monocyte phagocytosis over time and with/without the intervention
Intestinal barrier
时间窗: 6 months
Change in zonulin levels over time and with/without the intervention
endotoxin
时间窗: 6 months
Change in endotoxin levels serum over time and with/without the intervention
monocyte function surface receptor expression
时间窗: 6 months
Change in monocyte surface receptor expression over time and with/without the intervention
T cell immunophenotyping
时间窗: 6 months
Change in T cell subtypes over time and with/without the intervention
sCD14
时间窗: 6 months
Change in sCD14 levels over time and with/without the intervention
interleukin 23
时间窗: 6 months
Change in interleukin 23 serum levels over time and with/without the intervention
neutrophil function burst function
时间窗: 6 months
Change in neutrophil burst function over time and with/without the intervention
neutrophil function phagocytosis
时间窗: 6 months
Change in neutrophil phagocytosis function over time and with/without the intervention
B cells immunophenotyping
时间窗: 6 months
Change in B cell subtypes over time and with/without the intervention
Microbiome composition
时间窗: 6 months
16 sRNA sequencing
Interleukin 1b
时间窗: 6 months
Change in Interleukin 1b serum levels over time and with/without the intervention
interleukin 17
时间窗: 6 months
Change in interleukin 17 serum levels over time and with/without the intervention
Spirometry
时间窗: 6 months
Change in spirometry measurements over time and with/without the intervention
Gas diffusion
时间窗: 6 months
Change in pulmonary gas diffusion over time and with/without the intervention
neutrophil NET formation
时间窗: 6 months
Change in neutrophil NET formation over time and with/without the intervention
neutrophil surface receptor expression
时间窗: 6 months
Change in neutrophil surface receptor expression over time and with/without the intervention
monocyte burst
时间窗: 6 months
Change in monocyte burst over time and with/without the intervention
Lung volume
时间窗: 6 months
Change in lung volume over time and with/without the intervention
次要结局
未报告次要终点