Trials / Completed
CompletedNCT05195047
Efficacy and Safety of Oral Lactobacillus Plantarum GUANKE (CGMCC NO.21720) in Enhancement of Antibody Level After SARS-CoV-2 Vaccination (Trial 2)
Efficacy and Safety of Oral Lactobacillus Plantarum GUANKE (CGMCC NO.21720) in Enhancement of Antibody Level After SARS-CoV-2 Vaccination: A Prospective, Randomized, Double-blind, Placebo-Controlled Trial (Trial 2)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Peking University · Academic / Other
- Sex
- All
- Age
- 18 Years – 59 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | 1 week placebo(Week 1) | 1 week of consecutively consuming oral placebo (1 time/day) |
| DIETARY_SUPPLEMENT | 1 week of probiotics(Week 1) | 1 week of consecutively consuming oral probiotics (1 time/day) |
| DIETARY_SUPPLEMENT | 1 week placebo(Week 2) | 1 week of consecutively consuming oral placebo (1 time/day) |
| DIETARY_SUPPLEMENT | 1 week of probiotics(Week 2) | 1 week of consecutively consuming oral probiotics (1 time/day) |
| DIETARY_SUPPLEMENT | 1 week placebo(Week 3) | 1 week of consecutively consuming oral placebo (1 time/day) |
| DIETARY_SUPPLEMENT | 1 week of probiotics(Week 3) | 1 week of consecutively consuming oral probiotics (1 time/day) |
Timeline
- Start date
- 2022-02-27
- Primary completion
- 2022-08-21
- Completion
- 2022-08-21
- First posted
- 2022-01-18
- Last updated
- 2022-11-03
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05195047. Inclusion in this directory is not an endorsement.