SARS-CoV-2NCT05194033

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

A study testing Probiotics daily in people with SARS-CoV-2, run by Peking University at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for: SARS-CoV-2
What is being tested?: Probiotics daily
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 31 participants
Where: 2 sitesChina
Study dates: 9 Mar 2022to 19 May 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 59 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

18 ≤age ≤59 years;
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).
Not vaccinated third dose vaccination;
Voluntarily participate in the study with signed informed consent form.

Who cannot join

Pregnancy or lactation period;
Infected with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV);
Plan to vaccinate third dose of SARS-CoV-2 vaccine within 2 months;
History of autoimmune diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus, dry syndrome, etc.);
Previously infected with SARS-CoV-2 or close contact of SARS-CoV-2 infected individual;
Other SARS-CoV-2 vaccination history (not manufactured by Sino Biopharmaceutical Limited or SINOVAC BIOTECH CO., LTD.);

Show all 9Show fewer

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

Trial locations and contacts

2 sites in 1 country.

China2 sites

Beijing Pinggu Hospital
Beijing
Peking University Health Science Center Hospital
Beijing

Other trials in China

About this study

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)

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.

Read the 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.

Conditions: SARS-CoV-2
Being tested: Probiotics daily, Placebo daily
Keywords: Probiotic, lactobacillus plantarum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Probiotics dailyDietary supplement
Probiotics 1 time/day for 7 consecutive days
Placebo dailyDietary supplement
Placebo 1 time/day for 7 consecutive days

Study groups in NCT05194033
Study group	Role	What they receive
Probiotics	Experimental	The intervention group consumes oral probiotics 1 time/day for 7 consecutive days. Receives: Dietary Supplement: Probiotics daily
Placebos	Placebo comparator	The placebo group consumes oral placebo 1 time/day for 7 consecutive days. Receives: Dietary Supplement: Placebo daily

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 8 weeks
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.
Measured: 8 weeks

Secondary outcomes (11)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Mar 202219 May 2022

First posted18 Jan 2022
Study start9 Mar 2022
Primary completion19 May 2022
Study completion19 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (25)Papers the sponsor has linked to this study.
Other trials for SARS-CoV-2Studies of the same condition, open and under way.
More trials run by Peking UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: A prospective, randomized, double-blind, placebo parallel controlled clinical trial.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05194033
Sponsor's protocol ID: GUANKE-Trial 1
Status last verified: Jul 2022
First submitted: 12 Jan 2022
Last updated: 7 Jul 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Shrotri M, Navaratnam AMD, Nguyen V, Byrne T, Geismar C, Fragaszy E, Beale S, Fong WLE, Patel P, Kovar J, Hayward AC, Aldridge RW; Virus Watch Collaborative. Spike-antibody waning after second dose of BNT162b2 or ChAdOx1. Lancet. 2021 Jul 31;398(10298):385-387. doi: 10.1016/S0140-6736(21)01642-1. Epub 2021 Jul 17. No abstract available.
PubMed 34274038
Naaber P, Tserel L, Kangro K, Sepp E, Jurjenson V, Adamson A, Haljasmagi L, Rumm AP, Maruste R, Karner J, Gerhold JM, Planken A, Ustav M, Kisand K, Peterson P. Dynamics of antibody response to BNT162b2 vaccine after six months: a longitudinal prospective study. Lancet Reg Health Eur. 2021 Nov;10:100208. doi: 10.1016/j.lanepe.2021.100208. Epub 2021 Sep 6.
PubMed 34514454
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.
PubMed 30141154
Gorska A, Przystupski D, Niemczura MJ, Kulbacka J. Probiotic Bacteria: A Promising Tool in Cancer Prevention and Therapy. Curr Microbiol. 2019 Aug;76(8):939-949. doi: 10.1007/s00284-019-01679-8. Epub 2019 Apr 4.
PubMed 30949803
Huang Y, Wang X, Wang J, Wu F, Sui Y, Yang L, Wang Z. Lactobacillus plantarum strains as potential probiotic cultures with cholesterol-lowering activity. J Dairy Sci. 2013 May;96(5):2746-53. doi: 10.3168/jds.2012-6123. Epub 2013 Mar 15.
PubMed 23498020
Li J, Zhao F, Wang Y, Chen J, Tao J, Tian G, Wu S, Liu W, Cui Q, Geng B, Zhang W, Weldon R, Auguste K, Yang L, Liu X, Chen L, Yang X, Zhu B, Cai J. Gut microbiota dysbiosis contributes to the development of hypertension. Microbiome. 2017 Feb 1;5(1):14. doi: 10.1186/s40168-016-0222-x.
PubMed 28143587
Palmu J, Salosensaari A, Havulinna AS, Cheng S, Inouye M, Jain M, Salido RA, Sanders K, Brennan C, Humphrey GC, Sanders JG, Vartiainen E, Laatikainen T, Jousilahti P, Salomaa V, Knight R, Lahti L, Niiranen TJ. Association Between the Gut Microbiota and Blood Pressure in a Population Cohort of 6953 Individuals. J Am Heart Assoc. 2020 Aug 4;9(15):e016641. doi: 10.1161/JAHA.120.016641. Epub 2020 Jul 21.
PubMed 32691653
Khalesi S, Sun J, Buys N, Jayasinghe R. Effect of probiotics on blood pressure: a systematic review and meta-analysis of randomized, controlled trials. Hypertension. 2014 Oct;64(4):897-903. doi: 10.1161/HYPERTENSIONAHA.114.03469. Epub 2014 Jul 21.
PubMed 25047574
Wu Y, Zhang Q, Ren Y, Ruan Z. Effect of probiotic Lactobacillus on lipid profile: A systematic review and meta-analysis of randomized, controlled trials. PLoS One. 2017 Jun 8;12(6):e0178868. doi: 10.1371/journal.pone.0178868. eCollection 2017.
PubMed 28594860
Bock PM, Telo GH, Ramalho R, Sbaraini M, Leivas G, Martins AF, Schaan BD. The effect of probiotics, prebiotics or synbiotics on metabolic outcomes in individuals with diabetes: a systematic review and meta-analysis. Diabetologia. 2021 Jan;64(1):26-41. doi: 10.1007/s00125-020-05295-1. Epub 2020 Oct 13.
PubMed 33047170
Seddik HA, Bendali F, Gancel F, Fliss I, Spano G, Drider D. Lactobacillus plantarum and Its Probiotic and Food Potentialities. Probiotics Antimicrob Proteins. 2017 Jun;9(2):111-122. doi: 10.1007/s12602-017-9264-z.
PubMed 28271469
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.
PubMed 26690209
Ducrotte P, Sawant P, Jayanthi V. Clinical trial: Lactobacillus plantarum 299v (DSM 9843) improves symptoms of irritable bowel syndrome. World J Gastroenterol. 2012 Aug 14;18(30):4012-8. doi: 10.3748/wjg.v18.i30.4012.
PubMed 22912552
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.
PubMed 23017585
Miele E, Pascarella F, Giannetti E, Quaglietta L, Baldassano RN, Staiano A. Effect of a probiotic preparation (VSL#3) on induction and maintenance of remission in children with ulcerative colitis. Am J Gastroenterol. 2009 Feb;104(2):437-43. doi: 10.1038/ajg.2008.118. Epub 2009 Jan 20.
PubMed 19174792

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT05194033
Acronym / sponsor ID: GUANKE-Trial 1
Conditions: SARS-CoV-2
Keywords: Probiotic, lactobacillus plantarum
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Peking UniversityUniversity, hospital or other
Collaborators: Centers for Disease Control and Prevention, China, Beijing Pinggu District Hospital, Peking University Health Science Center
Study start: 9 Mar 2022 (actual)
Primary completion: 19 May 2022 (actual)
Study completion: 19 May 2022 (actual)
First posted: 18 Jan 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: A prospective, randomized, double-blind, placebo parallel controlled clinical trial.

Arm	Type	Receives
Probiotics	Experimental	Dietary Supplement: Probiotics dailyThe intervention group consumes oral probiotics 1 time/day for 7 consecutive days.
Placebos	Placebo comparator	Dietary Supplement: Placebo dailyThe placebo group consumes oral placebo 1 time/day for 7 consecutive days.

Who may qualify

Ages: 18 to 59 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

18 ≤age ≤59 years;
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).
Not vaccinated third dose vaccination;
Voluntarily participate in the study with signed informed consent form.

Key exclusion criteria (9 listed)

Pregnancy or lactation period;
Infected with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV);
Plan to vaccinate third dose of SARS-CoV-2 vaccine within 2 months;
History of autoimmune diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus, dry syndrome, etc.);
Previously infected with SARS-CoV-2 or close contact of SARS-CoV-2 infected individual;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Probiotics dailyProbiotics 1 time/day for 7 consecutive days	Dietary supplement	Probiotics
Placebo dailyPlacebo 1 time/day for 7 consecutive days	Dietary supplement	Placebos

Primary outcome

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

11 secondary outcomes

Antibody concentration
Time frame: 8 weeks
PBMC transcriptome expression
Time frame: 8 weeks
Serum cytokines
Time frame: 8 weeks
Serum neutralizing antibody positive rate
Time frame: 8 weeks
Serum neutralizing antibody positive conversion rate
Time frame: 8 weeks
Intestinal flora
Time frame: 8 weeks
Fecal viable culture
Time frame: 8 weeks
Fecal specific binding antibody IgA
Time frame: 8 weeks
Blood pressure
Time frame: 8 weeks
Blood glucose
Time frame: 8 weeks
Blood lipid
Time frame: 8 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
Background: PubMed 34274038Shrotri M, Navaratnam AMD, Nguyen V, Byrne T, Geismar C, Fragaszy E, Beale S, Fong WLE, Patel P, Kovar J, Hayward AC, Aldridge RW; Virus Watch Collaborative. Spike-antibody waning after second dose of BNT162b2 or ChAdOx1. Lancet. 2021 Jul 31;398(10298):385-387. doi: 10.1016/S0140-6736(21)01642-1. Epub 2021 Jul 17. No abstract available.
Background: PubMed 34514454Naaber P, Tserel L, Kangro K, Sepp E, Jurjenson V, Adamson A, Haljasmagi L, Rumm AP, Maruste R, Karner J, Gerhold JM, Planken A, Ustav M, Kisand K, Peterson P. Dynamics of antibody response to BNT162b2 vaccine after six months: a longitudinal prospective study. Lancet Reg Health Eur. 2021 Nov;10:100208. doi: 10.1016/j.lanepe.2021.100208. Epub 2021 Sep 6.
Background: PubMed 30141154Liu 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.
Background: PubMed 30949803Gorska A, Przystupski D, Niemczura MJ, Kulbacka J. Probiotic Bacteria: A Promising Tool in Cancer Prevention and Therapy. Curr Microbiol. 2019 Aug;76(8):939-949. doi: 10.1007/s00284-019-01679-8. Epub 2019 Apr 4.
Background: PubMed 23498020Huang Y, Wang X, Wang J, Wu F, Sui Y, Yang L, Wang Z. Lactobacillus plantarum strains as potential probiotic cultures with cholesterol-lowering activity. J Dairy Sci. 2013 May;96(5):2746-53. doi: 10.3168/jds.2012-6123. Epub 2013 Mar 15.
Background: PubMed 28143587Li J, Zhao F, Wang Y, Chen J, Tao J, Tian G, Wu S, Liu W, Cui Q, Geng B, Zhang W, Weldon R, Auguste K, Yang L, Liu X, Chen L, Yang X, Zhu B, Cai J. Gut microbiota dysbiosis contributes to the development of hypertension. Microbiome. 2017 Feb 1;5(1):14. doi: 10.1186/s40168-016-0222-x.
Background: PubMed 32691653Palmu J, Salosensaari A, Havulinna AS, Cheng S, Inouye M, Jain M, Salido RA, Sanders K, Brennan C, Humphrey GC, Sanders JG, Vartiainen E, Laatikainen T, Jousilahti P, Salomaa V, Knight R, Lahti L, Niiranen TJ. Association Between the Gut Microbiota and Blood Pressure in a Population Cohort of 6953 Individuals. J Am Heart Assoc. 2020 Aug 4;9(15):e016641. doi: 10.1161/JAHA.120.016641. Epub 2020 Jul 21.
Background: PubMed 25047574Khalesi S, Sun J, Buys N, Jayasinghe R. Effect of probiotics on blood pressure: a systematic review and meta-analysis of randomized, controlled trials. Hypertension. 2014 Oct;64(4):897-903. doi: 10.1161/HYPERTENSIONAHA.114.03469. Epub 2014 Jul 21.
Background: PubMed 28594860Wu Y, Zhang Q, Ren Y, Ruan Z. Effect of probiotic Lactobacillus on lipid profile: A systematic review and meta-analysis of randomized, controlled trials. PLoS One. 2017 Jun 8;12(6):e0178868. doi: 10.1371/journal.pone.0178868. eCollection 2017.
Background: PubMed 33047170Bock PM, Telo GH, Ramalho R, Sbaraini M, Leivas G, Martins AF, Schaan BD. The effect of probiotics, prebiotics or synbiotics on metabolic outcomes in individuals with diabetes: a systematic review and meta-analysis. Diabetologia. 2021 Jan;64(1):26-41. doi: 10.1007/s00125-020-05295-1. Epub 2020 Oct 13.
Background: PubMed 28271469Seddik HA, Bendali F, Gancel F, Fliss I, Spano G, Drider D. Lactobacillus plantarum and Its Probiotic and Food Potentialities. Probiotics Antimicrob Proteins. 2017 Jun;9(2):111-122. doi: 10.1007/s12602-017-9264-z.
Background: PubMed 26690209Kujawa-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.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yangfeng Wu principal investigator

Peking University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Probiotics daily in people with SARS-CoV-2, run by Peking University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The serum neutralizing antibody level of SARS-CoV-2. (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05194033, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.