Bifido- and Lactobacilli in Symptomatic Adult COVID-19 Outpatients

NCT04907877 | Completed

• 1 other identifier: MS-Resp-CoV-2-A0003
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

Brief Summary

There is evidence that some types of probiotics play a role in alleviation of symptoms of acute respiratory tract infections and bursting immune response to respiratory and enteric viruses. Available data serves a rationale for the study exploring a role of nutritional support with probiotics in adult outpatients with COVID-19. Hypothesis of the study is that a proposed mixture of lactobacilli and bifidobacteria facilitate faster recovery from COVID-19 and enhance specific immune response to SARS-CoV-2 antigens.

Conditions

COVID-19 Respiratory Infection

Outcome Measures

Primary Outcomes (1)

• Global symptom score

  Clinical score of Coronavirus disease-19; minimal score 0 (healthy), maximal score 36 (worst disease)

  10 days

Secondary Outcomes (4)

• 8 - point ordinal severity scale of coronavirus disease-19

  28 days

• Time to recovery

  28 days

• Percent of completely recovered patients

  28 days

• Hospitalization rate

  28 days

Other Outcomes (1)

• Anti-SARS-CoV-2 antibodies IgG response

  Days 0-5, day 28-35, month 6th

Study Arms (2)

Probiotic

EXPERIMENTAL

NordBiotic ImmunoVir, a mixute of bidido- and lactobacteria administered in a dose of 5 billion once a day for 28 days

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Maltodextrine administered once a day for 28 days

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Probiotic will be taken 1 time a day before breakfast for 28 days.

Probiotic

Placebo DIETARY_SUPPLEMENT

Placebo will be taken 1 time a day before breakfast for 28 days.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 - ≤ 65 years;
• Male or non-pregnant female;
• Informed virtual pre-consent and paper signed consent forms;
• Confirmed symptomatic COVID-19 lasting 0-5 days;
• Subject understands and agrees to comply with study procedures including triple blood analysis for anti-SARS-CoV-2 IgG;

You may not qualify if:

• Risk for the complicated course of COVID-19 due to:
• 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 ;
• Drug or alcohol abuse as suspected by investigator;
• History of persistent diarrhea of any cause;
• Use of pre- or probiotics during the last 2 weeks before enrollment;
• Allergy to any components of the TDS;
• Technical difficulties to perform virtual study visits.
• Inability to perform a blood test for antibodies after 6 months
• Inability to swallow capsules, or choking / coughing while eating

Sponsors & Collaborators

• Nordic Biotic Sp. z o.o.: lead

Study Sites (3)

Hemo Medica Ukraine Ltd

Uzhhorod, Zakarpatska, 88000, Ukraine

Location

Lviv State Center for Disease Control and Prevention

Lviv, 79014, Ukraine

Location

3rd City Clinical Hospital of Lviv

Lviv, 79016, Ukraine

Location

Related Publications (13)

• 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.

  PMID: 32287140 RESULT

• 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.

  PMID: 32406522 RESULT

• 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.

  PMID: 27547201 RESULT

• Van Tassell ML, Miller MJ. Lactobacillus adhesion to mucus. Nutrients. 2011 May;3(5):613-36. doi: 10.3390/nu3050613. Epub 2011 May 20.

  PMID: 22254114 RESULT

• 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.

  PMID: 33083549 RESULT

• 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.

  PMID: 33431578 RESULT

• 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.

  PMID: 23188495 RESULT

• 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.

  PMID: 22895087 RESULT

• 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.

  PMID: 24717726 RESULT

• 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.

  PMID: 27826541 RESULT

• 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.

  PMID: 19179052 RESULT

• 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.

  PMID: 28923425 RESULT

• 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.

  PMID: 38178223 DERIVED

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Zoriana Hoda, MD

  Lviv State Laboratory Center, Ministry of Health of Ukraine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 1, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: March 1, 2023
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

UA (3)