NCT04937556已完成不适用
Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of the Lactobacillus Probiotic Strain in the Immune Response in Participants Positive for SARS-CoV-2 (Severe Acute Respiratory Syndrome-Coronavirus-2) Infection.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Concentration of specific IgM (Immunoglobulin M) and IgG (Immunoglobulin G) antibodies for the SARS-CoV-2 virus.
研究概览
简要总结
An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic strain on the immune response in participants positive for SARS-CoV-2 infection.
The study duration will be 28 days, which includes 4 weeks product administration. Participants will be randomized assigned to one of the two study groups: the control group with placebo consumption and a probiotic consumption group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (18-65 years).
- •Mild infection by SARS-CoV-2 detected by PCR or Antigen.
- •Onset of COVID-19 symptoms up to 5 days before the day of inclusion
- •Without hospitalization or oxygen supplementation on the day of inclusion.
- •Signed written informed consent
排除标准
- •Serious SARS-CoV-2 infection requiring hospitalization or oxygen supply
- •Chronic diseases under regular medication (eg asthma, allergic rhinitis ...)
- •Congenital or acquired immunodeficiency
- •Body Mass Index (BMI)> 30
- •Coagulation disorders
- •Short bowel syndrome or any surgery on the gastrointestinal tract.
- •Metabolic disorders (diabetes, etc.).
- •Heart failure and cardiac medical history
- •Pregnant women.
- •HIV positive.
- •Immunocompromised
- •History of significant gastrointestinal diseases
- •Use of other probiotics during the last month.
- •Uncertainty about the willingness or ability of the participant to comply with the requirements of the protocol.
结局指标
主要结局
Concentration of specific IgM (Immunoglobulin M) and IgG (Immunoglobulin G) antibodies for the SARS-CoV-2 virus.
时间窗: 1 month
次要结局
- Duration of the symptoms produced by the SARS-CoV-2 infection(1 month)
- Percentage of participants with a negative result in the SARS-CoV-2 detection test by PCR (Polymerase Chain Reaction) at visit 2(1 month)
- Levels (pg/ml) of pro-inflammatory and anti-inflammatory markers in blood serum.(1 month)
- Severity of symptoms produced during SARS-CoV-2 infection(1 month)
- Percentage of participants with worsening of lower respiratory tract infections(1 month)
研究者
研究点 (1)
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