Bifido- and Lactobacilli in Symptomatic Adult COVID-19 Outpatients
NCT ID: NCT04907877
Last Updated: 2023-03-22
Study Results
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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COMPLETED
NA
70 participants
INTERVENTIONAL
2021-12-01
2023-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Probiotic
NordBiotic ImmunoVir, a mixute of bidido- and lactobacteria administered in a dose of 5 billion once a day for 28 days
Probiotic
Probiotic will be taken 1 time a day before breakfast for 28 days.
Placebo
Maltodextrine administered once a day for 28 days
Placebo
Placebo will be taken 1 time a day before breakfast for 28 days.
Interventions
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Probiotic
Probiotic will be taken 1 time a day before breakfast for 28 days.
Placebo
Placebo will be taken 1 time a day before breakfast for 28 days.
Eligibility Criteria
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Inclusion Criteria
2. Male or non-pregnant female;
3. Informed virtual pre-consent and paper signed consent forms;
4. Confirmed symptomatic COVID-19 lasting 0-5 days;
5. Subject understands and agrees to comply with study procedures including triple blood analysis for anti-SARS-CoV-2 IgG;
Exclusion Criteria
1.1. Hypertension; 1.2. Diabetes mellitus; 1.3. Immunosuppressive conditions; 1.4. Chronic pathology of the respiratory system ; 1.5. Chronic pathology of the cardiovascular system ; 1.6. Malignant tumor ; 1.7. Systemic inflammatory connective tissue disease ; 1.8. Cerebrovascular disease ; 1.9. Chronic hepatitis. Hepatic cirrhosis; 1.10. Inflammatory bowel diseases ; 1.11. Chronic kidney disease ;
2. Drug or alcohol abuse as suspected by investigator;
3. History of persistent diarrhea of any cause;
4. Use of pre- or probiotics during the last 2 weeks before enrollment;
5. Allergy to any components of the TDS;
6. Technical difficulties to perform virtual study visits.
7. Inability to perform a blood test for antibodies after 6 months
8. Inability to swallow capsules, or choking / coughing while eating
18 Years
65 Years
ALL
No
Sponsors
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Nordic Biotic Sp. z o.o.
INDUSTRY
Responsible Party
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Sergei Gerasymov, MD, PhD
Principal Investigator
Principal Investigators
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Zoriana Hoda, MD
Role: STUDY_DIRECTOR
Lviv State Laboratory Center, Ministry of Health of Ukraine
Locations
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Hemo Medica Ukraine Ltd
Uzhhorod, Zakarpatska, Ukraine
Lviv State Center for Disease Control and Prevention
Lviv, , Ukraine
3rd City Clinical Hospital of Lviv
Lviv, , Ukraine
Countries
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References
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Pan L, Mu M, Yang P, Sun Y, Wang R, Yan J, Li P, Hu B, Wang J, Hu C, Jin Y, Niu X, Ping R, Du Y, Li T, Xu G, Hu Q, Tu L. Clinical Characteristics of COVID-19 Patients With Digestive Symptoms in Hubei, China: A Descriptive, Cross-Sectional, Multicenter Study. Am J Gastroenterol. 2020 May;115(5):766-773. doi: 10.14309/ajg.0000000000000620.
Smyk W, Janik MK, Portincasa P, Milkiewicz P, Lammert F, Krawczyk M. COVID-19: Focus on the lungs but do not forget the gastrointestinal tract. Eur J Clin Invest. 2020 Sep;50(9):e13276. doi: 10.1111/eci.13276. Epub 2020 Jul 5.
Westermann C, Gleinser M, Corr SC, Riedel CU. A Critical Evaluation of Bifidobacterial Adhesion to the Host Tissue. Front Microbiol. 2016 Aug 5;7:1220. doi: 10.3389/fmicb.2016.01220. eCollection 2016.
Van Tassell ML, Miller MJ. Lactobacillus adhesion to mucus. Nutrients. 2011 May;3(5):613-36. doi: 10.3390/nu3050613. Epub 2011 May 20.
Olaimat AN, Aolymat I, Al-Holy M, Ayyash M, Abu Ghoush M, Al-Nabulsi AA, Osaili T, Apostolopoulos V, Liu SQ, Shah NP. The potential application of probiotics and prebiotics for the prevention and treatment of COVID-19. NPJ Sci Food. 2020 Oct 5;4:17. doi: 10.1038/s41538-020-00078-9. eCollection 2020.
Yeoh YK, Zuo T, Lui GC, Zhang F, Liu Q, Li AY, Chung AC, Cheung CP, Tso EY, Fung KS, Chan V, Ling L, Joynt G, Hui DS, Chow KM, Ng SSS, Li TC, Ng RW, Yip TC, Wong GL, Chan FK, Wong CK, Chan PK, Ng SC. Gut microbiota composition reflects disease severity and dysfunctional immune responses in patients with COVID-19. Gut. 2021 Apr;70(4):698-706. doi: 10.1136/gutjnl-2020-323020. Epub 2021 Jan 11.
Chai W, Burwinkel M, Wang Z, Palissa C, Esch B, Twardziok S, Rieger J, Wrede P, Schmidt MF. Antiviral effects of a probiotic Enterococcus faecium strain against transmissible gastroenteritis coronavirus. Arch Virol. 2013 Apr;158(4):799-807. doi: 10.1007/s00705-012-1543-0. Epub 2012 Nov 28.
Miettinen M, Pietila TE, Kekkonen RA, Kankainen M, Latvala S, Pirhonen J, Osterlund P, Korpela R, Julkunen I. Nonpathogenic Lactobacillus rhamnosus activates the inflammasome and antiviral responses in human macrophages. Gut Microbes. 2012 Nov-Dec;3(6):510-22. doi: 10.4161/gmic.21736. Epub 2012 Aug 16.
Nakayama Y, Moriya T, Sakai F, Ikeda N, Shiozaki T, Hosoya T, Nakagawa H, Miyazaki T. Oral administration of Lactobacillus gasseri SBT2055 is effective for preventing influenza in mice. Sci Rep. 2014 Apr 10;4:4638. doi: 10.1038/srep04638.
Gao X, Huang L, Zhu L, Mou C, Hou Q, Yu Q. Inhibition of H9N2 Virus Invasion into Dendritic Cells by the S-Layer Protein from L. acidophilus ATCC 4356. Front Cell Infect Microbiol. 2016 Oct 25;6:137. doi: 10.3389/fcimb.2016.00137. eCollection 2016.
Vouloumanou EK, Makris GC, Karageorgopoulos DE, Falagas ME. Probiotics for the prevention of respiratory tract infections: a systematic review. Int J Antimicrob Agents. 2009 Sep;34(3):197.e1-10. doi: 10.1016/j.ijantimicag.2008.11.005. Epub 2009 Jan 28.
Zimmermann P, Curtis N. The influence of probiotics on vaccine responses - A systematic review. Vaccine. 2018 Jan 4;36(2):207-213. doi: 10.1016/j.vaccine.2017.08.069. Epub 2017 Sep 18.
Kolesnyk PO, Paliy IH, Sydorchuk LP, Hoda ZP, Ivanchenko NO, Lych OS, Huley NR, Matsyura OI, Slyuzar ZL, Gerasymov SV. The role of nutritional support with probiotics in outpatients with symptomatic acute respiratory tract infections: a multicenter, randomized, double-blind, placebo-controlled dietary study. BMC Nutr. 2024 Jan 4;10(1):4. doi: 10.1186/s40795-023-00816-8.
Other Identifiers
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MS-Resp-CoV-2-A0003
Identifier Type: -
Identifier Source: org_study_id
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