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.
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.
研究组 & 干预措施
Probiotic: Lactobacillus salivarius + Vit D + Zinc
Lactobacillus strain during 28 days, approximately 1*10E9 colony forming unit (CFU) of L. salivarius in 1 capsule per day.
干预措施: Probiotic: Lactobacillus salivarius + Vit D + Zinc (Dietary Supplement)
Placebo
Placebo supplement in 1 capsule per day during 28 days.
干预措施: Placebo (Dietary Supplement)
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
- Severity of symptoms produced during SARS-CoV-2 infection(1 month)
- Percentage of participants with worsening of lower respiratory tract infections(1 month)
- 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)