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

Not Applicable

Completed

• Conditions: SARS-CoV-2
• Interventions: Dietary Supplement: Probiotics daily; Dietary Supplement: Placebo daily

• Registration Number: NCT05194033
• Lead Sponsor: Peking University

Brief 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 had completed two doses 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 ratio to intervention group or placebo control group.

Study Timeline

• Study First Submitted: 2022-01-12
• Study First Submitted QC: 2022-01-12
• Study First Posted: 2022-01-18
• Study Start: 2022-03-09
• Primary Completion: 2022-05-19
• Study Completion: 2022-05-19
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-03
• Last Update Posted: 2022-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

1. 18 ≤age ≤59 years;
2. Vaccinated with two doses of SARS-CoV-2 vaccine (manufactured by Sino Biopharmaceutical Limited or SINOVAC BIOTECH CO., LTD.) (≥6 months from the time of vaccination).
3. Not vaccinated third dose vaccination;
4. Voluntarily participate in the study with signed informed consent form.

Exclusion criteria:

1. Pregnancy or lactation period;
2. Infected with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV);
3. Plan to vaccinate third dose of SARS-CoV-2 vaccine within 2 months;
4. History of autoimmune diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus, dry syndrome, etc.);
5. Previously infected with SARS-CoV-2 or close contact of SARS-CoV-2 infected individual;
6. Other SARS-CoV-2 vaccination history (not manufactured by Sino Biopharmaceutical Limited or SINOVAC BIOTECH CO., LTD.);
7. End-stage cancer or other terminal diseases with life expectancy <6 month;
8. History of severe cardiovascular and cerebrovascular diseases, such as heart failure, uncontrolled coronary heart disease, cardiomyopathy, uncontrolled arrhythmia,or history of myocardial or cerebral infarction within past six months;
9. Participating in other clinical trials.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics	Probiotics daily	The intervention group consumes oral probiotics 1 time/day for 7 consecutive days.
Placebos	Placebo daily	The placebo group consumes oral placebo 1 time/day for 7 consecutive days.

Primary Outcome Measures

Name	Time	Method
The serum neutralizing antibody level of SARS-CoV-2.	8 weeks	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.
T-cell response level	8 weeks	Test of T-cell response level by spot-forming cell(SFC) counting, using Champspot III enzyme-linked spot automated image analysis system.

Secondary Outcome Measures

Name	Time	Method
Intestinal flora	8 weeks	The level of intestinal flora.
Antibody concentration	8 weeks	The binding antibody concentration of S protein IgG and IgA in SARS-CoV-2 serum.
Fecal viable culture	8 weeks	The culture of fecal viable
Fecal specific binding antibody IgA	8 weeks	The specific binding antibody IgA of fecal
Serum neutralizing antibody positive rate	8 weeks	The positive rate of serum neutralizing antibody.
Blood lipid	8 weeks	The level of blood lipid.
Serum cytokines	8 weeks	The test of serum cytokines
Blood pressure	8 weeks	The level of blood pressure.
PBMC transcriptome expression	8 weeks	The expression of PBMC transcriptome
Serum neutralizing antibody positive conversion rate	8 weeks	The positive conversion rate of serum neutralizing antibody.
Blood glucose	8 weeks	The level of blood glucose.

Trial Locations

Locations (2)

Beijing Pinggu Hospital; 🇨🇳 Beijing, China

Peking University Health Science Center Hospital; 🇨🇳 Beijing, China