Exploratory Study on the Effects of Probiotic Supplementation on SARS-CoV-2 Antibody Response in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 2
- 主要终点
- SARS-CoV-2 specific antibodies
研究概览
简要总结
This study will explore how a well-known probiotic strain L. reuteri DSM 17938 impacts SARS-CoV-2 specific antibody response upon and after infection in healthy adults.
详细描述
After giving their informed consent, the study subjects will complete screening procedures to assess their eligibility for the study (Visit 1). Participants deemed suitable for the study will be randomized into two study arms (placebo, probiotic) before undergoing a baseline visit (Visit 2) before the start of the intervention period. During the 6-month intervention period, the participants will attend study visits at 3 months (Visit 3) into the intervention as well as at the end of intervention (at 6 months, Visit 4). Blood, saliva, and faecal samples will be collected at visits 2-4. In addition to sampling, during the whole intervention period, the participants will fill out a weekly questionnaire in which they are asked to record any possible symptoms of COVID-19. The participants' dietary habits are assessed via a food frequency questionnaire (FFQ) before the start of the intervention period. Also, the participants are asked to maintain their habitual diet and lifestyle as well as not to consume any other probiotic or prebiotic supplements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •Age between 18-60
排除标准
- •Previous diagnosis of COVID-19 (by positive PCR) or previous confirmation of seropositivity to SARS-CoV-2
- •Body Mass Index over 35 or under 16
- •Current diagnosis of cancer or ongoing cancer treatment in the last 12 months
- •Diabetes mellitus
- •Cardiovascular disorder in need of pharmaceutical treatment
- •Chronic kidney disease
- •Chronic lung disease with decreased lung capacity
- •Chronic liver disease with liver cirrhosis
- •Current diagnosis of dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation
- •Chronic neurological/neurodegenerative disease (e.g. Parkinson's disease)
- •Decreased function of the adrenal cortex (e.g. Addison's disease)
- •Autoimmune disease (e.g. rheumatoid arthritis)
- •Chronic pain syndromes (e.g. fibromyalgia)
- •Pregnancy or breast-feeding
- •Immunodeficiency due to disease or ongoing medical treatment
- •Regular intake of anti-inflammatory and/or other immunosuppressive medication within the last 3 months
- •Use of anti-depressants within the last 3 months
- •Antimicrobial treatment within the last 12 weeks before baseline sampling
- •Regular intake of probiotics, as well as nutritional supplements or herb products that might affect intestinal function within the last 4 weeks if the investigator considers that those could affect study outcome
- •Inability to maintain current diet and lifestyle during the study period
- •Alcohol or drug abuse
- •Any clinically significant present or past disease/condition which the investigator considers to possibly interfere with the study outcome or increase the risk for severe form of COVID-19
结局指标
主要结局
SARS-CoV-2 specific antibodies
时间窗: 3 months (interim analysis) or at 6 months
Change in SARS-CoV-2 specific IgG/IgM antibodies in serum between the study arms
次要结局
- Duration of COVID-19 symptoms measured by a weekly symptom questionnaire(3 months + 6 months)
- Maintenance of SARS-CoV-2 seroconversion in seropositive individuals(3 months + 6 months)
- Intestinal inflammation(3 months + 6 months)
- Indirect marker of intestinal permeability(3 months + 6 months)
- Blood group A antigen antibodies(3 months + 6 months)
- T cell activation(3 months + 6 months)
- Severity of COVID-19 symptoms measured by Ordinal Scale for Clinical Improvement (scale 0-7, a lower score corresponds to a better outcome)(3 months + 6 months)
- Secretory IgA (sIgA) antibodies(3 months + 6 months)
- Tn antigen antibodies(3 months + 6 months)
- Cytokines(3 months + 6 months)
- Intestinal barrier function(3 months + 6 months)
- Blood group B antigen antibodies(3 months + 6 months)
- Innate immune system activation(3 months + 6 months)
- Total antibodies(3 months + 6 months)
- B cell activation(3 months + 6 months)