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COVID-19 Respiratory InfectionProCOVIDNCT04907877

Bifido- and Lactobacilli in Symptomatic Adult COVID-19 Outpatients

A study testing Probiotic in people with COVID-19 Respiratory Infection, run by Nordic Biotic Sp. z o.o. at 3 sites in Ukraine.

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

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
COVID-19 Respiratory Infection
What is being tested?
Probiotic
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
3 sitesUkraine
Study dates
1 Dec 2021to 1 Mar 2023
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • Risk for the complicated course of COVID-19 due to:
  • 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 ;
  • 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;
Show all 9Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

Ukraine3 sites

  • Lviv State Center for Disease Control and Prevention

    Lviv, 79014

  • 3rd City Clinical Hospital of Lviv

    Lviv, 79016

  • Hemo Medica Ukraine Ltd

    Uzhhorod, Zakarpatska, 88000

Other trials in Ukraine

About this study

Official title: Role of Nutritional Support With Probiotics in Adult Outpatients With Symptomatic COVID-19: a Randomized Dietary Study

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.

Read the detailed description

One hundred adults with confirmed (PCR or antigen test) symptomatic COVID-19 lasting upto 5 days will be screened for the study. When the subject meets enrollment criteria, he/she will be randomized to take an investigational product (probiotic, test dietary supplement, TDS), a mixture of lactobacilli and bifidobacteria or placebo 1 time a day before breakfast for 28 days after enrollment. During observation, the patient will keep Respiratory Illness Diary. Blood serum will be collected at baseline, day 0-5 (Nurse Visit 1), after 28-35 days (Nurse visit 2), and 6 months (Nurse visit 3) for evaluation of anti-SARS-CoV-2 antibodies to nucleocapsid and spike antigents. In 3 months, investigator/family physician will collect Post-COVID-19 Questionnaire

Being tested
Probiotic, Placebo

What participants receive

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

  • ProbioticDietary supplement

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

  • PlaceboDietary supplement

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

Study groups in NCT04907877
Study groupRoleWhat they receive
ProbioticExperimentalNordBiotic ImmunoVir, a mixute of bidido- and lactobacteria administered in a dose of 5 billion once a day for 28 days
Receives: Dietary Supplement: Probiotic
PlaceboPlacebo comparatorMaltodextrine administered once a day for 28 days
Receives: Dietary Supplement: Placebo

What is being measured

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

  1. Global symptom score

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

    Measured: 10 days

Secondary outcomes (4)

  1. 8 - point ordinal severity scale of coronavirus disease-19

    World Health Organization scale; score 0 - healthy, score 8 - death

    Measured: 28 days

  2. Time to recovery

    Day when patient symptom score is 0

    Measured: 28 days

  3. Percent of completely recovered patients

    Patients with symptom score is 0

    Measured: 28 days

  4. Hospitalization rate

    Percent hospitalized due to COVID-19

    Measured: 28 days

Timeline

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

  1. First posted1 Jun 2021
  2. Study start1 Dec 2021
  3. Primary completion1 Dec 2022
  4. Study completion1 Mar 2023

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04907877
Sponsor's protocol ID
MS-Resp-CoV-2-A0003
Acronym
ProCOVID
Status last verified
Mar 2023
First submitted
28 May 2021
Last updated
22 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Not applicable as not decided yet

Publications

  • 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.

    PubMed 32287140

  • 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.

    PubMed 32406522

  • 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.

    PubMed 27547201

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

    PubMed 22254114

  • 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.

    PubMed 33083549

  • 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.

    PubMed 33431578

  • 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.

    PubMed 23188495

  • 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.

    PubMed 22895087

  • 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.

    PubMed 24717726

  • 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.

    PubMed 27826541

  • 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.

    PubMed 19179052

  • 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.

    PubMed 28923425

  • 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.

    PubMed 38178223

Questions about this trial

What is this clinical trial studying?

A study testing Probiotic in people with COVID-19 Respiratory Infection, run by Nordic Biotic Sp. z o.o. at 3 sites in Ukraine.

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 5 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 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Ukraine. 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?

Global symptom score (time frame: 10 days). 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 NCT04907877, which also lists 13 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 22 Mar 2023.

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