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AzTrials

SARS-CoV-2NCT05195047

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

A study testing 1 week of probiotics(Week 1) and 1 week of probiotics(Week 2) 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.

Official record
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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?
1 week of probiotics(Week 1) and 1 week of probiotics(Week 2)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
2 sitesChina
Study dates
27 Feb 2022to 21 Aug 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).
  • Plan to vaccinate third dose vaccination (manufactured by Sino Biopharmaceutical Limited or SINOVAC BIOTECH CO., LTD.);
  • 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);
  • 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.);
  • 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 2)

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 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.

Conditions
SARS-CoV-2
Being tested
1 week placebo(Week 1), 1 week of probiotics(Week 1), 1 week placebo(Week 2), 1 week of probiotics(Week 2), 1 week placebo(Week 3)
Keywords
Probiotic, lactobacillus plantarum

What participants receive

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

  • 1 week placebo(Week 1)Dietary supplement

    1 week of consecutively consuming oral placebo (1 time/day)

  • 1 week of probiotics(Week 1)Dietary supplement

    1 week of consecutively consuming oral probiotics (1 time/day)

  • 1 week placebo(Week 2)Dietary supplement

    1 week of consecutively consuming oral placebo (1 time/day)

  • 1 week of probiotics(Week 2)Dietary supplement

    1 week of consecutively consuming oral probiotics (1 time/day)

  • 1 week placebo(Week 3)Dietary supplement

    1 week of consecutively consuming oral placebo (1 time/day)

  • 1 week of probiotics(Week 3)Dietary supplement

    1 week of consecutively consuming oral probiotics (1 time/day)

Study groups in NCT05195047
Study groupRoleWhat they receive
Probiotics-Placebo-PlaceboExperimental1 week of consecutively consuming oral probiotics (1 time/day) followed by SARS-CoV-2 vaccination, then 2 weeks of consecutively consuming oral placebo (1 time/day).
Receives: Dietary Supplement: 1 week of probiotics(Week 1); Dietary Supplement: 1 week placebo(Week 2); Dietary Supplement: 1 week placebo(Week 3)
Placebo-Probiotics-PlaceboExperimental1 week of consecutively consuming oral placebo (1 time/day) followed by SARS-CoV-2 vaccination, then consuming oral probiotics (1 time/day) for 1 week and placebo (1 time/day) for 1 week (1 time/day) respectively.
Receives: Dietary Supplement: 1 week placebo(Week 1); Dietary Supplement: 1 week of probiotics(Week 2); Dietary Supplement: 1 week placebo(Week 3)
Placebo-Placebo-ProbioticsExperimental1 week of consecutively consuming oral placebo (1 time/day) followed SARS-CoV-2 vaccination, then consuming oral placebo for 1 week (1 time/day) and probiotics for 1 week (1 time/day) respectively.
Receives: Dietary Supplement: 1 week placebo(Week 1); Dietary Supplement: 1 week placebo(Week 2); Dietary Supplement: 1 week of probiotics(Week 3)
PlaceboPlacebo comparator1 week of consecutively consuming oral placebo (1 time/day) followed by SARS-CoV-2 vaccination, then 2 weeks of consecutively consuming oral placebo (1 time/day).
Receives: Dietary Supplement: 1 week placebo(Week 1); Dietary Supplement: 1 week placebo(Week 2); Dietary Supplement: 1 week placebo(Week 3)

What is being measured

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

  1. 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: 12-24 weeks

  2. 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: 12-24 weeks

Secondary outcomes (11)

  1. Antibody concentration

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

    Measured: 12-24 weeks

  2. PBMC transcriptome expression

    The expression of PBMC transcriptome

    Measured: 12-24 weeks

  3. Serum cytokines

    The test of serum cytokines

    Measured: 12-24 weeks

  4. Serum neutralizing antibody positive rate

    The positive rate of serum neutralizing antibody.

    Measured: 12-24 weeks

  5. Serum neutralizing antibody positive conversion rate

    The positive conversion rate of serum neutralizing antibody.

    Measured: 12-24 weeks

  6. Intestinal flora

    The level of intestinal flora.

    Measured: 12-24 weeks

  7. Fecal viable culture

    The culture of fecal viable

    Measured: 12-24 weeks

  8. Fecal specific binding antibody IgA

    The specific binding antibody IgA of fecal

    Measured: 12-24 weeks

  9. Blood pressure

    The level of blood pressure.

    Measured: 12-24 weeks

  10. Blood glucose

    The level of blood glucose.

    Measured: 12-24 weeks

  11. Blood lipid

    The level of blood lipid.

    Measured: 12-24 weeks

Timeline

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

  1. First posted18 Jan 2022
  2. Study start27 Feb 2022
  3. Primary completion21 Aug 2022
  4. Study completion21 Aug 2022

Resources

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
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05195047
Sponsor's protocol ID
GUANKE-Trial 2
Status last verified
Nov 2022
First submitted
12 Jan 2022
Last updated
3 Nov 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

Questions about this trial

What is this clinical trial studying?

A study testing 1 week of probiotics(Week 1) and 1 week of probiotics(Week 2) 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 8 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 3 Nov 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: 12-24 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 NCT05195047, 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 3 Nov 2022.

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