Evaluation of a Synbiotic Formula in Patient With COVID-19
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes in gut microbiome
研究概览
简要总结
A series of microbiota were correlated inversely with the disease severity and virus load. Gut microbiota could play a role in modulating host immune response and potentially influence disease severity and outcomes.
详细描述
Coronavirus can target multiple organs due to the hyperactive immune response with cytokine storms. Several studies have detected SARS-CoV-2 in stool samples and indicated that the virus could spread via faeces. Importantly, COVID-19 uses the same receptor as SARS and this doorway can also be found in the intestine. The cell entry receptor, known as angiotensin converting enzyme 2 (ACE2) receptor mediate entry of SARS-CoV-2 and is highly expressed in small bowel enterocytes. ACE2 is important in controlling intestinal inflammation and its disruption may lead to diarrhoea. In our previous study, stool samples from 15 patients with COVID-19 were analysed. Depleted symbionts and gut dysbiosis were noted even after patients were detected negative of SARS-CoV-2. A series of microbiota were correlated inversely with the disease severity and virus load. Gut microbiota could play a role in modulating host immune response and potentially influence disease severity and outcomes.
In July 2020, there are more than 15 billion confirmed cases globally with 620 thousand deaths. Currently, there are more than 2000 confirmed cases of COVID-19 in Hong Kong. It is important to rebalance the gut microbiota in COVID-19 patients and to improve the symptoms and the quality of life of these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 or above; and
- •A confirmed diagnosis of SARS-Cov.2 infection using the PCR according to the standard of according to Centre for Health Protection, Department of Health, HK and released from isolation at recruitment.
- •Written informed consent obtained
排除标准
- •Known allergy or intolerance to the intervention product or its components
- •Any known medical condition that would prevent taking oral probiotics or increase risks associated with probiotics including but not limited to inability to swallow/aspiration risk and no other methods of delivery (e.g., no G/J tube)
- •Known increased infection risk due to immunosuppression such as:
- •Prior organ or hematopoietic stem cell transplant
- •Neutropenia (ANC <500 cells/ul)
- •HIV and CD4 <200 cells/ul
- •Known increased infection risk due to endovascular due to:
- •Rheumatic heart disease
- •Congenital heart defect,
- •Mechanical heart valves
- •Endocarditis
- •Endovascular grafts
- •Permanent endovascular devices such as permanent (not short-term) hemodialysis catheters, pacemakers, or defibrillators
- •Documented pregnancy
结局指标
主要结局
Changes in gut microbiome
时间窗: week 5
Changes in the gut microbiome (bacteria, virome and fungome) measured by metagenomics at week 5 compared to baseline
次要结局
- Changes in fecal bacteria metabolites(weeks 2, 4, 5, 8 and months 3, 6, 9 and 12)
- Change in plasma cytokines including IL-6, IL-IB, TNF-a and CXCL-10(week 5)
- Change in Quality of life measured by SF-12(weeks 2, 4, 5, 8 and months 3, 6, 9 and 12)
- Duration of gastrointestinal symptoms(4 weeks)
- Trend in symptom score(weeks 2, 4, 5, 8 and months 3, 6, 9 and 12)
- Change in Quality of life measured by EQ-5D-5L(weeks 2, 4, 5, 8 and months 3, 6, 9 and 12)
- Adverse event assessment(3 months)
研究者
Siew Chien NG
Professor
Chinese University of Hong Kong