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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)

Sponsor
Peking University (Other)
Overall Status
Completed
CT.gov ID
NCT05194033
Collaborator
Centers for Disease Control and Prevention, China (Other), Beijing Pinggu District Hospital (Other), Peking University Health Science Center Hospital (Other)
31
Enrollment
2
Locations
2
Arms
2.3
Actual Duration (Months)
15.5
Patients Per Site
6.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Probiotics daily
  • Dietary Supplement: Placebo daily
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A prospective, randomized, double-blind, placebo parallel controlled clinical trial.A prospective, randomized, double-blind, placebo parallel controlled clinical trial.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Other
Official Title:
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 1)
Actual Study Start Date :
Mar 9, 2022
Actual Primary Completion Date :
May 19, 2022
Actual Study Completion Date :
May 19, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Probiotics

The intervention group consumes oral probiotics 1 time/day for 7 consecutive days.

Dietary Supplement: Probiotics daily
Probiotics 1 time/day for 7 consecutive days
Placebo Comparator: Placebos

The placebo group consumes oral placebo 1 time/day for 7 consecutive days.

Dietary Supplement: Placebo daily
Placebo 1 time/day for 7 consecutive days

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. Antibody concentration [8 weeks]

    The binding antibody concentration of S protein IgG and IgA in SARS-CoV-2 serum.

  2. PBMC transcriptome expression [8 weeks]

    The expression of PBMC transcriptome

  3. Serum cytokines [8 weeks]

    The test of serum cytokines

  4. Serum neutralizing antibody positive rate [8 weeks]

    The positive rate of serum neutralizing antibody.

  5. Serum neutralizing antibody positive conversion rate [8 weeks]

    The positive conversion rate of serum neutralizing antibody.

  6. Intestinal flora [8 weeks]

    The level of intestinal flora.

  7. Fecal viable culture [8 weeks]

    The culture of fecal viable

  8. Fecal specific binding antibody IgA [8 weeks]

    The specific binding antibody IgA of fecal

  9. Blood pressure [8 weeks]

    The level of blood pressure.

  10. Blood glucose [8 weeks]

    The level of blood glucose.

  11. Blood lipid [8 weeks]

    The level of blood lipid.

Other Outcome Measures

  1. Safety indicators [8 weeks]

    Adverse events and serious adverse events.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 59 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Pinggu Hospital Beijing China
2 Peking University Health Science Center Hospital Beijing China

Sponsors and Collaborators

  • Peking University
  • Centers for Disease Control and Prevention, China
  • Beijing Pinggu District Hospital
  • Peking University Health Science Center Hospital

Investigators

  • Principal Investigator: Yangfeng Wu, Peking University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yangfeng Wu, Professor of Epidemiology and Sciences in Clincial Research, Peking University
ClinicalTrials.gov Identifier:
NCT05194033
Other Study ID Numbers:
  • GUANKE-Trial 1
First Posted:
Jan 18, 2022
Last Update Posted:
Jul 7, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yangfeng Wu, Professor of Epidemiology and Sciences in Clincial Research, Peking University
Probiotic
lactobacillus plantarum

Study Results

No Results Posted as of Jul 7, 2022