Efficacy and Safety of Oral Lactobacillus Plantarum GUANKE (CGMCC NO.21720) in Enhancement of Antibody Level After SARS-CoV-2 Vaccination (Trial 1)
NCT ID: NCT05194033
Last Updated: 2022-07-07
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
31 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-03-09
Study Completion Date
2022-05-19
Brief Summary
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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.
Provide a reference for determining the appropriate oral regimen. Provide necessary parameters for estimating the sample size of confirmatory clinical trial.
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Detailed Description
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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.
Conditions
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SARS-CoV-2
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
A prospective, randomized, double-blind, placebo parallel controlled clinical trial.
Primary Study Purpose
OTHER
Blinding Strategy
TRIPLE
Participants
Investigators
Outcome Assessors
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.
Study Groups
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Probiotics
The intervention group consumes oral probiotics 1 time/day for 7 consecutive days.
Group Type
EXPERIMENTAL
Probiotics daily
Intervention Type
DIETARY_SUPPLEMENT
Probiotics 1 time/day for 7 consecutive days
Placebos
The placebo group consumes oral placebo 1 time/day for 7 consecutive days.
Group Type
PLACEBO_COMPARATOR
Placebo daily
Intervention Type
DIETARY_SUPPLEMENT
Placebo 1 time/day for 7 consecutive days
Interventions
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Probiotics daily
Probiotics 1 time/day for 7 consecutive days
Intervention Type
DIETARY_SUPPLEMENT
Placebo daily
Placebo 1 time/day for 7 consecutive days
Intervention Type
DIETARY_SUPPLEMENT
Eligibility Criteria
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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.
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.
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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
59 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Centers for Disease Control and Prevention, China
OTHER_GOV
Sponsor Role
collaborator
Beijing Pinggu District Hospital
OTHER
Sponsor Role
collaborator
Peking University Health Science Center Hospital
UNKNOWN
Sponsor Role
collaborator
Peking University
OTHER
Sponsor Role
lead
Responsible Party
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Yangfeng Wu
Professor of Epidemiology and Sciences in Clincial Research
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Yangfeng Wu
Role: PRINCIPAL_INVESTIGATOR
Peking University
Locations
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Beijing Pinggu Hospital
Beijing, , China
Site Status
Peking University Health Science Center Hospital
Beijing, , China
Site Status
Countries
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China
References
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Liu YW, Liong MT, Tsai YC. New perspectives of Lactobacillus plantarum as a probiotic: The gut-heart-brain axis. J Microbiol. 2018 Sep;56(9):601-613. doi: 10.1007/s12275-018-8079-2. Epub 2018 Aug 23.
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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.
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Fuentes MC, Lajo T, Carrion JM, Cune J. Cholesterol-lowering efficacy of Lactobacillus plantarum CECT 7527, 7528 and 7529 in hypercholesterolaemic adults. Br J Nutr. 2013 May 28;109(10):1866-72. doi: 10.1017/S000711451200373X. Epub 2012 Sep 28.
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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):305. doi: 10.3390/nu11020305.
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Hakansson A, Andren Aronsson C, Brundin C, Oscarsson E, Molin G, Agardh D. Effects of Lactobacillus plantarum and Lactobacillus paracasei on the Peripheral Immune Response in Children with Celiac Disease Autoimmunity: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Nutrients. 2019 Aug 16;11(8):1925. doi: 10.3390/nu11081925.
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Chong HX, Yusoff NAA, Hor YY, Lew LC, Jaafar MH, Choi SB, Yusoff MSB, Wahid N, Abdullah MFIL, Zakaria N, Ong KL, Park YH, Liong MT. Lactobacillus plantarum DR7 alleviates stress and anxiety in adults: a randomised, double-blind, placebo-controlled study. Benef Microbes. 2019 Apr 19;10(4):355-373. doi: 10.3920/BM2018.0135. Epub 2019 Mar 18.
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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.
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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.
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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):1466. doi: 10.3390/microorganisms9071466.
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Other Identifiers
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GUANKE-Trial 1
Identifier Type: -
Identifier Source: org_study_id
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