SARS-CoV-2
Conditions
Keywords
Probiotic, lactobacillus plantarum
Brief summary
Preliminarily explore the effect of oral probiotics in SARS-CoV-2 serum neutralizing antibody titer level and T cell response level (spot formation cell counting). Provide a reference for determining the appropriate oral regimen. Provide necessary parameters for estimating the sample size of confirmatory clinical trial.
Detailed description
In selected communities or assigned clinical trial institutions, participants who intend to complete the third dose of SARS-CoV-2 vaccination will be invited in this study. Informed consent form will give to potential participants with well explained of trial contents during baseline. Participants who gave their signed informed consent form will be blocked randomized in a 1:1:1:1 ratio to intervention group A, intervention group B, intervention group C, or placebo group D.
Interventions
DIETARY_SUPPLEMENT1 week placebo(Week 1)
1 week of consecutively consuming oral placebo (1 time/day)
DIETARY_SUPPLEMENT1 week of probiotics(Week 1)
1 week of consecutively consuming oral probiotics (1 time/day)
DIETARY_SUPPLEMENT1 week placebo(Week 2)
1 week of consecutively consuming oral placebo (1 time/day)
DIETARY_SUPPLEMENT1 week of probiotics(Week 2)
1 week of consecutively consuming oral probiotics (1 time/day)
DIETARY_SUPPLEMENT1 week placebo(Week 3)
1 week of consecutively consuming oral placebo (1 time/day)
DIETARY_SUPPLEMENT1 week of probiotics(Week 3)
1 week of consecutively consuming oral probiotics (1 time/day)
Sponsors
Centers for Disease Control and Prevention, China
Beijing Pinggu District Hospital
Peking University Health Science Center Hospital
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
This study is double-blinded, which neither participants nor investigators know the results of intervention. In addition, laboratory test of blood samples will also be conducted without knowing the randomization results of participants to ensure the evaluation of outcome measure is objective.
Intervention model description
A prospective, randomized, double-blind, placebo parallel controlled clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
1. 18 ≤age ≤59 years; 2. Vaccinated with two doses of SARS-CoV-2 vaccine (manufactured by Sino Biopharmaceutical Limited or SINOVAC BIOTECH CO., LTD.) (≥6 months from the time of vaccination). 3. Plan to vaccinate third dose vaccination (manufactured by Sino Biopharmaceutical Limited or SINOVAC BIOTECH CO., LTD.); 4. Voluntarily participate in the study with signed informed consent form.
Exclusion criteria
1. Pregnancy or lactation period; 2. Infected with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); 3. History of autoimmune diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus, dry syndrome, etc.); 4. Previously infected with SARS-CoV-2 or close contact of SARS-CoV-2 infected individual; 5. Other SARS-CoV-2 vaccination history (not manufactured by Sino Biopharmaceutical Limited or SINOVAC BIOTECH CO., LTD.); 6. End-stage cancer or other terminal diseases with life expectancy \<6 month; 7. History of severe cardiovascular and cerebrovascular diseases, such as heart failure, uncontrolled coronary heart disease, cardiomyopathy, uncontrolled arrhythmia, or history of myocardial or cerebral infarction within past six months; 8. Participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| T-cell response level | 12-24 weeks | Test of T-cell response level by spot-forming cell(SFC) counting, using Champspot III enzyme-linked spot automated image analysis system. |
| The serum neutralizing antibody level of SARS-CoV-2. | 12-24 weeks | The serum neutralizing antibody level of SARS-CoV-2 is determined by serum neutralization test, which is used to determine the serum dilution that protects 50% cells from cytopathic effect. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PBMC transcriptome expression | 12-24 weeks | The expression of PBMC transcriptome |
| Serum cytokines | 12-24 weeks | The test of serum cytokines |
| Serum neutralizing antibody positive rate | 12-24 weeks | The positive rate of serum neutralizing antibody. |
| Serum neutralizing antibody positive conversion rate | 12-24 weeks | The positive conversion rate of serum neutralizing antibody. |
| Intestinal flora | 12-24 weeks | The level of intestinal flora. |
| Fecal specific binding antibody IgA | 12-24 weeks | The specific binding antibody IgA of fecal |
| Blood pressure | 12-24 weeks | The level of blood pressure. |
| Blood glucose | 12-24 weeks | The level of blood glucose. |
| Blood lipid | 12-24 weeks | The level of blood lipid. |
| Fecal viable culture | 12-24 weeks | The culture of fecal viable |
| Antibody concentration | 12-24 weeks | The binding antibody concentration of S protein IgG and IgA in SARS-CoV-2 serum. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety indicators | 12-24 weeks | Adverse events and serious adverse events. |
Countries
China
Outcome results
None listed