Efficacy and Safety of Lactobacillus Plantarum and Pediococcus Acidilactici as Co-adjuvant Therapy for Reducing the Risk of Severe Disease in Adults With SARS-CoV-2 and Its Modulation of the Fecal Microbiota: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Severity progression of COVID-19
研究概览
简要总结
Clinical research focused to evaluate the effect as coadyuvant of a combination of L. plantarum and P. acidilactici in adults positive for SARS-CoV-2 with mild clinical COVID-19 symptoms. Main objective is to evaluate how this combination of probiotics reduce the risk to progress to moderate or severe COVID and associated advantages such as reduce the risk of death. Adittionnally this RCT is launching to explore the benefits of this combination of strains to modulate fecal microbiome and explore how this correlate with clinical improvement.
详细描述
Randomized controlled trial (RCT) to evaluate safety and efficacy of Lactobacillus plantarum CECT 30292, Lactobacillus plantarum CECT 7484, Lactobacillus plantarum CECT 7485 y P. acidilactici CECT 7483, one dose a day to reduce the risk of subjects with mild COVID-19 to evolute to moderate or severe disease. As secondary aims this trial is intented to evaluate the effect of this strains combinations to reduce the frequency and severity of gastrointestinal COVID-19 symptoms and lung abnormalities, to reduce the viral load, modulate the levels of IgG/IgM, and positively modify the fecal microbiota.
300 adults, 18 to 60 years, RTq-PCR positive for SARS-CoV-2, with mild COVID-19, and SpO2 > 90%, living in Mexico city (2,200m over the sea level) will be randomized, after sign of informed consent to receive a combintation of Lactobacillus plantarum CECT 30292, Lactobacillus plantarum CECT 7484, Lactobacillus plantarum CECT 7485 y P. acidilactici CECT 7483 one a day orally or placebo for 30 days.
Clinical severity, lung abnormalities (x-rays), viral load, IgG/IgM levels, and fecal microbiome will be evaluated at COVID-19 research center before randomization. Participants will be invited to remain at home and clinical evolution, temperature, SpO2 will be recorder and reported remotely during the 30 days intervention.
On days 15 and 30, participants will be invited to return to COVID-19 research center to take samples to evaluate evolution of viral load, IgG/IgM and fecal microbiome.
During the 30-days intervention period outcomes such as clinical progression, need of hospitalization, admission to Intensive Care Unit and death will be evaluated
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All study staff, including the Principal Investigator and the persons performing the subject assessments, will be blinded during the study. Sealed individual treatment code envelopes will be kept at the clinic to be able to break the code if any emergency occurs, as judged by the Investigator
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women or men, >18y to 60 years
- •RTq-PCR to COVID positive
- •Presence of cough, fever, dyspnoea, or headache, onset <= 7 days
- •Mild severity of COVID-19
- •Peripheral Oxygen Saturation (SpO2) >90%
- •Able to read, understand and sign the informed consent
- •To have at least one family member to collaborate with the follow-up in the clinical findings at beginning and throughout of the study.
排除标准
- •Severe Obesity (BMI>40)
- •Uncontrolled Type II diabetes (HbA1C >8.0)
- •Uncontrolled systolic hypertension (>160mmdeHg)
- •Acute pancreatitis
- •Chronic diarrhea or constipation
- •Inflammatory bowel disease
- •Blood clotting disease
- •Immunosuppression derived from Cancer, post-transplantation, auto-immune disease or HIV
- •Severe and active seasonal allergies
- •Pregnancy or lactation
- •Glucose 6P-dehydrogenase deficiency
- •Regular use of probiotic or antibiotic within 2 weeks before entering the trial
- •Severe or uncontrolled Chronic Respiratory Diseases (Asthma, COPD or Cystic Fibrosis)
结局指标
主要结局
Severity progression of COVID-19
时间窗: 30 days
Frequency of randomized subjects who progress from mild to moderate or severe COVID-19, or remission, as evaluated by WHO Clinical Progression Scale
Stay at ICU
时间窗: 30 days
Length of stay at Intensive Care Unit (ICU)
Mortality ratio
时间窗: 30 days
Mortality ratio for all causes related to COVID-19
次要结局
- Lung abnormalities(30 days)
- Viral load(30 days)
- Fecal microbiome(30 days)
- Adverse events(30 days)
- Levels of immunoglobulins(30 days)
- Gastrointestinal manifestations, where 0 means good health status and 5 worse status(30 days)
- Change on Serum Biomarkers(Days 1st, 15th and 30th after randomization)
- Duration of Individual Symptoms(30 days)