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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention, China | OTHER_GOV |
| Beijing Pinggu District Hospital | OTHER |
| Peking University Health Science Center Hospital | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics-Placebo-Placebo | Experimental | 1 week of consecutively consuming oral probiotics (1 time/day) followed by SARS-CoV-2 vaccination, then 2 weeks of consecutively consuming oral placebo (1 time/day). |
|
| Placebo-Probiotics-Placebo | Experimental | 1 week of consecutively consuming oral placebo (1 time/day) followed by SARS-CoV-2 vaccination, then consuming oral probiotics (1 time/day) for 1 week and placebo (1 time/day) for 1 week (1 time/day) respectively. |
|
| Placebo-Placebo-Probiotics | Experimental | 1 week of consecutively consuming oral placebo (1 time/day) followed SARS-CoV-2 vaccination, then consuming oral placebo for 1 week (1 time/day) and probiotics for 1 week (1 time/day) respectively. |
|
| Placebo | Placebo Comparator | 1 week of consecutively consuming oral placebo (1 time/day) followed by SARS-CoV-2 vaccination, then 2 weeks of consecutively consuming oral placebo (1 time/day). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 week placebo(Week 1) | Dietary Supplement | 1 week of consecutively consuming oral placebo (1 time/day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 12-24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody concentration | The binding antibody concentration of S protein IgG and IgA in SARS-CoV-2 serum. | 12-24 weeks |
| PBMC transcriptome expression | The expression of PBMC transcriptome |
| Measure | Description | Time Frame |
|---|---|---|
| Safety indicators | Adverse events and serious adverse events. | 12-24 weeks |
Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yangfeng Wu, PHD | Peking University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Pinggu Hospital | Beijing | China | ||||
| Peking University Health Science Center Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34274038 | Background | Shrotri M, Navaratnam AMD, Nguyen V, Byrne T, Geismar C, Fragaszy E, Beale S, Fong WLE, Patel P, Kovar J, Hayward AC, Aldridge RW; Virus Watch Collaborative. Spike-antibody waning after second dose of BNT162b2 or ChAdOx1. Lancet. 2021 Jul 31;398(10298):385-387. doi: 10.1016/S0140-6736(21)01642-1. Epub 2021 Jul 17. No abstract available. | |
| 34514454 |
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A prospective, randomized, double-blind, placebo parallel controlled clinical trial.
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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.
| 1 week of probiotics(Week 1) | Dietary Supplement | 1 week of consecutively consuming oral probiotics (1 time/day) |
|
| 1 week placebo(Week 2) | Dietary Supplement | 1 week of consecutively consuming oral placebo (1 time/day) |
|
| 1 week of probiotics(Week 2) | Dietary Supplement | 1 week of consecutively consuming oral probiotics (1 time/day) |
|
| 1 week placebo(Week 3) | Dietary Supplement | 1 week of consecutively consuming oral placebo (1 time/day) |
|
| 1 week of probiotics(Week 3) | Dietary Supplement | 1 week of consecutively consuming oral probiotics (1 time/day) |
|
| 12-24 weeks |
| Serum cytokines | The test of serum cytokines | 12-24 weeks |
| Serum neutralizing antibody positive rate | The positive rate of serum neutralizing antibody. | 12-24 weeks |
| Serum neutralizing antibody positive conversion rate | The positive conversion rate of serum neutralizing antibody. | 12-24 weeks |
| Intestinal flora | The level of intestinal flora. | 12-24 weeks |
| Fecal viable culture | The culture of fecal viable | 12-24 weeks |
| Fecal specific binding antibody IgA | The specific binding antibody IgA of fecal | 12-24 weeks |
| Blood pressure | The level of blood pressure. | 12-24 weeks |
| Blood glucose | The level of blood glucose. | 12-24 weeks |
| Blood lipid | The level of blood lipid. | 12-24 weeks |
| Beijing |
| China |
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