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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
44
1 week of consecutively consuming oral placebo (1 time/day)
1 week of consecutively consuming oral probiotics (1 time/day)
1 week of consecutively consuming oral placebo (1 time/day)
Beijing Pinggu Hospital
Beijing, China
Peking University Health Science Center Hospital
Beijing, China
The serum neutralizing antibody level of SARS-CoV-2.
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.
Time frame: 12-24 weeks
T-cell response level
Test of T-cell response level by spot-forming cell(SFC) counting, using Champspot III enzyme-linked spot automated image analysis system.
Time frame: 12-24 weeks
Antibody concentration
The binding antibody concentration of S protein IgG and IgA in SARS-CoV-2 serum.
Time frame: 12-24 weeks
PBMC transcriptome expression
The expression of PBMC transcriptome
Time frame: 12-24 weeks
Serum cytokines
The test of serum cytokines
Time frame: 12-24 weeks
Serum neutralizing antibody positive rate
The positive rate of serum neutralizing antibody.
Time frame: 12-24 weeks
Serum neutralizing antibody positive conversion rate
The positive conversion rate of serum neutralizing antibody.
Time frame: 12-24 weeks
Intestinal flora
The level of intestinal flora.
Time frame: 12-24 weeks
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1 week of consecutively consuming oral probiotics (1 time/day)
1 week of consecutively consuming oral placebo (1 time/day)
1 week of consecutively consuming oral probiotics (1 time/day)
Fecal viable culture
The culture of fecal viable
Time frame: 12-24 weeks
Fecal specific binding antibody IgA
The specific binding antibody IgA of fecal
Time frame: 12-24 weeks
Blood pressure
The level of blood pressure.
Time frame: 12-24 weeks
Blood glucose
The level of blood glucose.
Time frame: 12-24 weeks
Blood lipid
The level of blood lipid.
Time frame: 12-24 weeks