An Evaluation of a Synbiotic Formula for Symptom Improvement in Hospitalised Patients With COVID-19 Infection
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Combined symptom score
研究概览
简要总结
In December 2019, a cluster of pneumonia cases of unidentified cause emerged in Wuhan,was identified as the culprit of this disease currently being identified as "Coronavirus Disease 2019" (COVID-19) by World Health Organization.
Coronavirus was found to not only target the patient's lungs but also multiple organs. Around 2-33% of Coronavirus Disease-19 patients developed gastrointestinal symptoms. Studies have shown that Severe acute respiratory syndrome coronavirus 2 (SAR-CoV-2) was found in patient's feces, suggesting that the virus can spread through feces. 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.
The investigators are uncertain about the impact of synbiotic on patients with COVID-19. However, a therapeutic strategy aiming at investigating the gut Imicrobiota of patients with COVID-9 who take synbiotic or not, leading to lesser progression to severe disease, less hospital stay and improved quality of life.
详细描述
In December 2019, a cluster of pneumonia cases of unidentified cause emerged in Wuhan, Hubei province, China. In early January, a novel betacoronavirus forming another clade within the subgenus sarbecovirus, now named SARS-CoV-2, was identified as the culprit of this disease currently being identified as "Coronavirus Disease 2019" (COVID-19) by WHO.
Coronavirus was found to not only target the patient's lungs, but also multiple organs. Around 2-33% of COVID-19 patients developed gastrointestinal symptoms. Studies have shown that SAR-CoV-2 was found in patient's feces, suggesting that the virus can spread through feces. 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 million confirmed cases globally with 620 thousand deaths. Currently, there are more than 2000 confirmed cases of COVID-19 in Hong Kong. The investigators are uncertain about the impact of synbiotic on patients with COVID-19. However, a therapeutic strategy aiming at investigating the gut Imicrobiota of patients with COVID-9 who take synbiotic or not, leading to lesser progression to severe disease, less hospital stay and improved quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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 at recruitment and that require admission to the hospitalization area; and
- •Written informed consent is obtained
排除标准
- •Subjects admitted to Intensive Care Unit or on ventilator
- •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 history or active endocarditis
- •Recent on CAPD or hemodialysis-
- •Documented pregnancy
研究组 & 干预措施
Health supplements + standard care
28 days of health supplements (Synbiotic) daily plus standard care
干预措施: Health supplements (Other)
Standard care
No intervention
结局指标
主要结局
Combined symptom score
时间窗: 4 weeks
Combined symptom score improvement of the first 4 weeks. Symptoms score assessment ranges from 20-80. The higher the score, the worse the symptoms.
次要结局
- Number of admission to Intensive Care Unit(4 weeks)
- Trend of symptom score(4 weeks)
- Gastrointestinal symptoms(4 weeks)
- Clinical improvement(4 weeks)
- Time to develop antibody against SARS-CoV-2(16 days)
- Quality of life measured by EQ-5D-5L(4 weeks)
- Quality of life measured by SF-12(4 weeks)
- Duration of hospital stay(up to 3 months)
- Time to negative PCR(through study completion, an average of 1 year)
- Changes in fecal bacteria metabolites(weeks 2, 4, 5 and 8 months 3, 6, 9 and 12)
- Change in plasma cytokines level(week 2 and week 5)
- Changes in the gut microbiome(weeks 1, 2, 3, 4, 5, 8 and months 3, 6, 9 and 12)
- Number of subjects with home discharge(4 weeks)
- Number of mortality(4 weeks)
- Number of days absent from work(3 months)
- Change of quality of life questionnaire(week 8, months 3, 6, 9 and 12)
- Number of adverse event(3 months)
研究者
Siew Chien NG
Professor
Chinese University of Hong Kong