Efficacy and Safety of Oral Lactobacillus Plantarum GUANKE (CGMCC NO.21720) in Enhancement of Antibody Level After SARS-CoV-2 Vaccination (Trial 2)

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.

Conditions

• SARS-CoV-2

Interventions

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)

Sponsors & Collaborators

• Centers for Disease Control and Prevention, China

  collaborator OTHER_GOV

• Beijing Pinggu District Hospital

  collaborator OTHER

• Peking University Health Science Center Hospital

  collaborator UNKNOWN

• Peking University

  lead OTHER

Principal Investigators

• Yangfeng Wu, PHD · Peking University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

59 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-02-27

Primary Completion

2022-08-21

Completion

2022-08-21

Countries

• China

Study Locations