Modulation of Gut Microbiota to Enhance Health and Immunity of Vulnerable Individuals During COVID-19 Pandemic
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 453
- 试验地点
- 1
- 主要终点
- Adverse events/Serious adverse events
研究概览
简要总结
The novel coronavirus infection (COVID-19) caused by the SARS-CoV-2 virus is now a pandemic and has culminated major morbidity and mortality globally. Studies have shown that patients with underlying type 2 diabetes mellitus (DM), obesity, old age and hypertension had a higher risk of developing severe COVID-19 infection and mortality related to COVID-19.Emerging evidence has shown that gut microbiota plays an important role in the pathogenesis of COVID-19.
详细描述
HYPOTHESIS We hypothesize that modulating the gut microbiota with a microbiome immunity formula can rebalance the gut microbiota in populations at risk of infection, like, patients with type 2 DM and elderlies and can lower the number of hospitalisation and reduce side effects associated with COVID-19 vaccination.
AIM We aim to evaluate the efficacy of modulating gut microbiota with a microbiome immunity formula in vulnerable subjects (patients with underlying type 2 DM and elderlies) in improving immune functions, reducing adverse events associated with COVID-19 vaccinations and reducing hospitalisation in susceptible individuals during the COVID-19 pandemic.
STUDY DESIGN This is a double-blinded, randomized, active-placebo controlled study comparing a microbiome immunity formula and placebo in enhancing immunity and reducing hospitalisation within one year. Except two kinds of subjects (Substudy 1: Patients with Type 2 DM and Substudy 2: Elderly individual) will be included in respective substudy, all other methodologies are the same. In each substudy, at least half of the recruited subjects will plan to receive COVID-19 vaccination and start to take the study products after vaccination. Recruited subjects will be randomised to receive a microbiome immunity formula or active placebo for 3 months, with another 9 months follow-up after completion of study products.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, 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
- 否
入选标准
- •Inclusion Criteria:
- •Age 18 years - below 65 years
- •A confirmed diagnosis of type 2 DM for ≥ 3 months with stable control (i.e. no change in DM medications in recent 2 months)
- •Written informed consents obtained
排除标准
- •Known history of confirmed COVID-19 infection
- •Known active sepsis or active malignancy
- •Known increased infection risk due to underlying immunosuppressed state which includes:
- •Prior organ or hematopoietic stem cell transplant
- •Neutropenia with absolute neutrophil count (ANC) <500 cells/ul at the time of study inclusion
- •Known HIV infection with CD4 <200 cells/ul at the time of study inclusion
- •On concomitant immunosuppressants or corticosteroid at a dose of prednisolone equivalent dose 10mg or more for more than 3 months
- •Known history or active infective endocarditis
- •On peritoneal dialysis or haemodialysis
- •Documented pregnancy
- •Inclusion Criteria:
- •Age 65 years and above
- •Written informed consents obtained
- •Exclusion Criteria:
- •Known history of confirmed COVID-19 infection
- •Known active sepsis or active malignancy
- •Known increased infection risk due to underlying immunosuppressed state which includes:
- •Prior organ or hematopoietic stem cell transplant
- •Neutropenia with absolute neutrophil count (ANC) <500 cells/ul at the time of study inclusion
- •Known HIV infection with CD4 <200 cells/ul at the time of study inclusion
- •On concomitant immunosuppressants, chemotherapies or corticosteroid at a dose of prednisolone equivalent dose 10mg or more for more than 3 months
- •Known history or active infective endocarditis
- •On peritoneal dialysis or haemodialysis
- •Known active malignancy
- •Known terminal illness with life expectancy less than 3 months
研究组 & 干预措施
Active arm
Subject will be instructed to take microbiome immunity formula 2 sachets daily for a total of 12 weeks.
干预措施: Microbiome immunity formula (Dietary Supplement)
Placebo arm
Subject will be instructed to take active placebo daily for a total of 12 weeks.
干预措施: Active placebo (Dietary Supplement)
结局指标
主要结局
Adverse events/Serious adverse events
时间窗: within 6 months
Proportion of patients who presented with new symptoms/diseases which exerted unfavourable impacts on subjects. Serious adverse events are those adverse clinical events that resulted in hospital admission and/or death
次要结局
- Immunogenicity of the COVID-19 vaccine(3 months and 6 months)
- Change in gut microbiome(1, 3, 6, and 12 months)
- Changes in plasma inflammatory cytokines(3 months and 6 months)
- Restoration of gut dysbiosis(1, 3, 6 and 12 months)
- Number of unscheduled hospitalisation and clinic visits(1, 3, 6, and 12 months)
- Changes of quality of life(1, 3, 6, and 12 months)
- Changes in glycaemic control(1, 6 and 12 months)
研究者
Mak Wing Yan
Assistant Professor
Chinese University of Hong Kong