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

SARS-CoV-2 Clinical Trial

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 2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05195047
• Other study ID #: GUANKE-Trial 2
• Status: Completed
• Phase: N/A
• Start date: February 27, 2022
• Est. completion date: August 21, 2022

Study information

• Verified date: November 2022
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 21, 2022
• Est. primary completion date: August 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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. Plan to vaccinate third dose vaccination (manufactured by Sino Biopharmaceutical Limited or SINOVAC BIOTECH CO., LTD.);

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. History of autoimmune diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus, dry syndrome, etc.);

4. Previously infected with SARS-CoV-2 or close contact of SARS-CoV-2 infected individual;

5. Other SARS-CoV-2 vaccination history (not manufactured by Sino Biopharmaceutical Limited or SINOVAC BIOTECH CO., LTD.);

6. End-stage cancer or other terminal diseases with life expectancy <6 month;

7. 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;

8. Participating in other clinical trials.

Related Conditions & MeSH terms

• SARS-CoV-2

Intervention

Dietary Supplement:
• 1 week placebo(Week 1)
1 week of consecutively consuming oral placebo (1 time/day)
• 1 week of probiotics(Week 1)
1 week of consecutively consuming oral probiotics (1 time/day)
• 1 week placebo(Week 2)
1 week of consecutively consuming oral placebo (1 time/day)
• 1 week of probiotics(Week 2)
1 week of consecutively consuming oral probiotics (1 time/day)
• 1 week placebo(Week 3)
1 week of consecutively consuming oral placebo (1 time/day)
• 1 week of probiotics(Week 3)
1 week of consecutively consuming oral probiotics (1 time/day)

Locations

Country	Name	City	State
China	Beijing Pinggu Hospital	Beijing
China	Peking University Health Science Center Hospital	Beijing

Sponsors (4)

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

Country where clinical trial is conducted

China, 

References & Publications (25)

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Hwang YH, Park S, Paik JW, Chae SW, Kim DH, Jeong DG, Ha E, Kim M, Hong G, Park SH, Jung SJ, Lee SM, Na KH, Kim J, Chung YC. Efficacy and Safety of Lactobacillus Plantarum C29-Fermented Soybean (DW2009) in Individuals with Mild Cognitive Impairment: A 12-Week, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Nutrients. 2019 Feb 1;11(2). pii: E305. doi: 10.3390/nu11020305. — View Citation

Kageyama Y, Nishizaki Y, Aida K, Yayama K, Ebisui T, Akiyama T, Nakamura T. Lactobacillus plantarum induces innate cytokine responses that potentially provide a protective benefit against COVID-19: A single-arm, double-blind, prospective trial combined with an in vitro cytokine response assay. Exp Ther Med. 2022 Jan;23(1):20. doi: 10.3892/etm.2021.10942. Epub 2021 Nov 2. — View Citation

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Kujawa-Szewieczek A, Adamczak M, Kwiecien K, Dudzicz S, Gazda M, Wiecek A. The Effect of Lactobacillus plantarum 299v on the Incidence of Clostridium difficile Infection in High Risk Patients Treated with Antibiotics. Nutrients. 2015 Dec 4;7(12):10179-88. doi: 10.3390/nu7125526. — View Citation

Lee A, Lee YJ, Yoo HJ, Kim M, Chang Y, Lee DS, Lee JH. Consumption of Dairy Yogurt Containing Lactobacillus paracasei ssp. paracasei, Bifidobacterium animalis ssp. lactis and Heat-Treated Lactobacillus plantarum Improves Immune Function Including Natural Killer Cell Activity. Nutrients. 2017 May 31;9(6). pii: E558. doi: 10.3390/nu9060558. — View Citation

Lee MC, Tu YT, Lee CC, Tsai SC, Hsu HY, Tsai TY, Liu TH, Young SL, Lin JS, Huang CC. Lactobacillus plantarum TWK10 Improves Muscle Mass and Functional Performance in Frail Older Adults: A Randomized, Double-Blind Clinical Trial. Microorganisms. 2021 Jul 8;9(7). pii: 1466. doi: 10.3390/microorganisms9071466. — View Citation

Lew LC, Hor YY, Yusoff NAA, Choi SB, Yusoff MSB, Roslan NS, Ahmad A, Mohammad JAM, Abdullah MFIL, Zakaria N, Wahid N, Sun Z, Kwok LY, Zhang H, Liong MT. Probiotic Lactobacillus plantarum P8 alleviated stress and anxiety while enhancing memory and cognition in stressed adults: A randomised, double-blind, placebo-controlled study. Clin Nutr. 2019 Oct;38(5):2053-2064. doi: 10.1016/j.clnu.2018.09.010. Epub 2018 Sep 19. — View Citation

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Liu YW, Liong MT, Chung YE, Huang HY, Peng WS, Cheng YF, Lin YS, Wu YY, Tsai YC. Effects of Lactobacillus plantarum PS128 on Children with Autism Spectrum Disorder in Taiwan: A Randomized, Double-Blind, Placebo-Controlled Trial. Nutrients. 2019 Apr 11;11(4). pii: E820. doi: 10.3390/nu11040820. — View Citation

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety indicators	Adverse events and serious adverse events.	12-24 weeks
Primary	The serum neutralizing antibody level of SARS-CoV-2.	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.	12-24 weeks
Primary	T-cell response level	Test of T-cell response level by spot-forming cell(SFC) counting, using Champspot III enzyme-linked spot automated image analysis system.	12-24 weeks
Secondary	Antibody concentration	The binding antibody concentration of S protein IgG and IgA in SARS-CoV-2 serum.	12-24 weeks
Secondary	PBMC transcriptome expression	The expression of PBMC transcriptome	12-24 weeks
Secondary	Serum cytokines	The test of serum cytokines	12-24 weeks
Secondary	Serum neutralizing antibody positive rate	The positive rate of serum neutralizing antibody.	12-24 weeks
Secondary	Serum neutralizing antibody positive conversion rate	The positive conversion rate of serum neutralizing antibody.	12-24 weeks
Secondary	Intestinal flora	The level of intestinal flora.	12-24 weeks
Secondary	Fecal viable culture	The culture of fecal viable	12-24 weeks
Secondary	Fecal specific binding antibody IgA	The specific binding antibody IgA of fecal	12-24 weeks
Secondary	Blood pressure	The level of blood pressure.	12-24 weeks
Secondary	Blood glucose	The level of blood glucose.	12-24 weeks
Secondary	Blood lipid	The level of blood lipid.	12-24 weeks