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Efficacy and Safety of Oral Lactobacillus Plantarum GUANKE (CGMCC NO.21720) in Enhancement of Antibody Level After SARS-CoV-2 Vaccination (Trial 1)

NCT05194033 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2022-07-07

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Probiotics daily

Probiotics 1 time/day for 7 consecutive days

DIETARY_SUPPLEMENT

Placebo daily

Placebo 1 time/day for 7 consecutive days

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 · 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
2022-03-09
Primary Completion
2022-05-19
Completion
2022-05-19

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05194033 on ClinicalTrials.gov