Monitoring the Efficacy of a Probiotic Dietary Supplement SmartProbio C in Patients With Severe COVID-19 Infection

NCT05474144 | Completed

• 1 other identifier: 123666
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the study is to test the efficacy of the probiotic SmartProbio C in patients with a severe course of COVID-19 infection. Patients were randomly divided into two arms between the probiotic group and the placebo group. They were further divided into four groups according to 1) BMI (Body mass index; \<=30/\>30), 2) age (\<=65/\>65), 3) CRP (C-reactive protein; \<=100/\>100), 4) chronic lung disease (yes/no). Gut microbiome analysis and its changes in selected parameters (amount of lactobacilli, bifidobacteria, Akkermansia, Proteobacteria, Firmicutes/Bacteroidetes ratio) were chosen as the primary endpoint. Other assessed indicators include:

• Tracking of time to clinical improvement by two points on a seven-point ordinal scale for clinical improvement according to R\&D Blueprint: COVID-19 Therapeutic Trial Synopsis (WHO, 2020) or time to hospital discharge (whichever comes first)
• Monitoring the length of oxygen dependence
• Monitoring of laboratory markers of inflammation - serum peripheral blood CRP levels
• Monitoring of mortality

Conditions

COVID-19

Keywords

COVID-19; probiotics; probiotic supplementation

Outcome Measures

Primary Outcomes (1)

• Gut microbiome

  Changes in selected parameters of gut microbiome (amount of lactobacilli, bifidobacteria, Akkermansia, Proteobacteria, and Firmicutes/Bacteroidetes ratio) were chosen as the primary endpoint.

  The first sample was taken at the beginning of hospitalization before the start of supplementation, the second at discharge from the hospital, but not later than on the 14th day of hospitalization.

Secondary Outcomes (4)

• Length of hospitalisation

  From the date of admission to hospital until discharge from hospital or above defined two point improvement, whichever comes first

• Monitoring the length of oxygen dependence

  From the beginning of the provision of HFOT (high flow oxygen therapy) to the end of the provision of HFOT

• CRP (C-reactive protein) monitoring

  On the first day of admission to hospital and on the day of hospital discharge, but no later than 14th day

• Monitoring mortality rates

  From the date of admission to hospital until discharge from hospital or death, whichever comes first

Study Arms (2)

Verum

EXPERIMENTAL

Patients received probiotic supplement SmartProbio C, one capsule twice a day - mornings and evenings before meal - for a period of 2 weeks.

Dietary Supplement: SmartProbio C

Placebo

PLACEBO COMPARATOR

Patients received placebo consisting of purified maltodextrin, one capsule twice a day - mornings and evenings before meal - for a period of 2 weeks.

Dietary Supplement: Placebo

Interventions

SmartProbio C DIETARY_SUPPLEMENT

Probiotic supplement consisting of 19 strains (Lactobacillus acidophilus NCFM, Bifidobacterium lactis, subsp. Infantis Bi-07, Lactobacillus rhamnosus LR22, Lactobacillus acidophilus LA14, Lactobacillus rhamnosus LGG, Bifidobacterium lactis HN019, Bifidobacterium lactis Bl-04, Lactobacillus acidophilus LA 11 ONLLY, Lactobacillus rhamnosus HN001, Lactobacillus plantarum LP ONLLY, Lactobacillus casei LC18, Bifidobacterium breve BB8, Lactobacillus reuteri LE16, Bifidobacterium lactis BI516, Streptococcus thermophilus ST6, Bifidobacterium animalis BA77, Bifidobacterium bifidum BB47, Bifidobacterium longum BL88 ONLLY, Bifidobacterium infantis BI211) in different ratios. Probiotic mixture enclosed in HPMC (hydroxypropylmethylcelulose) capsule, 25 billion CFU (colony-forming units) in each capsule. As a filling agent mix of inulin and maltodextrin was used. Dosage twice a day.

Verum

Placebo DIETARY_SUPPLEMENT

Placebo. HPMC (hydroxypropylmethylcelulose) capsule filled with maltodextrin. Dosage twice a day.

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is willing and able to provide informed consent prior to any study procedure.
• Age at the time of screening between 18 and 85 years inclusive.
• Coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) or immunochromatographic detection of SARS CoV-2 specific antigens no more than three days prior to randomization.
• COVID-19 symptoms lasting less than or equal to seven days, including.
• Subject is currently hospitalized and requires medical care due to COVID-19 disease and was admitted at most two days prior to randomization.

You may not qualify if:

• Participation in any other clinical trial of an experimental treatment for COVID-19 disease.
• Concomitant treatment of COVID-19 with other non-standard-of-care medications less than 24 hours prior to initiation of the study intervention dosing (excluding remdesivir, corticosteroids, casirivimab, imdevimab, or bamlanivimab).
• Immunosuppressant treatment three months prior to hospital admission (excluding topical and inhaled corticosteroids or systemically administered corticosteroids at a dose equivalent to \<40 mg Prednisone)
• Necessity of invasive pulmonary ventilation.
• Patients with known primary or secondary immunodeficiency.
• History of Crohn's disease or ulcerative colitis.
• Abnormal screening laboratory results - laboratory abnormalities that, in the opinion of the investigator, will interfere with completion of participation in the clinical trial or will interfere with the results of the trial.
• Participation in another clinical trial of a drug or medical device, or less than 30 days have elapsed since the completion of participation in another trial or use of the investigational drug or device.
• Other probiotic supplementation.
• Hypersensitivity to any ingredient of a product administered during a clinical trial.
• Women who are pregnant or breastfeeding.
• Patients with preterminal and terminal organ failure (COPD GOLD 3 and 4, CKD G4 and G5, NYHA 3 and 4).
• Any condition that, in the opinion of the investigator, may compromise the patient's ability to provide informed consent and/or comply with all required study procedures.

Sponsors & Collaborators

• Medi Pharma Vision: lead
• Veterinary Research Institute: collaborator
• Brno University Hospital: collaborator

Study Sites (2)

Medi Pharma Vision

Brno, 61200, Czechia

Location

Brno University Hospital

Brno, 62500, Czechia

Location

Related Publications (7)

• Adler Sorensen C, Fuglsang E, Jorgensen CS, Laursen RP, Larnkjaer A, Molgaard C, Ritz C, Michaelsen KF, Krogfelt KA, Frokiaer H. Probiotics and the immunological response to infant vaccinations; a double-blind randomized controlled trial. Clin Microbiol Infect. 2019 Apr;25(4):511.e1-511.e7. doi: 10.1016/j.cmi.2018.07.031. Epub 2018 Aug 9.

  PMID: 30099133 BACKGROUND

• Baud D, Dimopoulou Agri V, Gibson GR, Reid G, Giannoni E. Using Probiotics to Flatten the Curve of Coronavirus Disease COVID-2019 Pandemic. Front Public Health. 2020 May 8;8:186. doi: 10.3389/fpubh.2020.00186. eCollection 2020. No abstract available.

  PMID: 32574290 BACKGROUND

• Bottari B, Castellone V, Neviani E. Probiotics and Covid-19. Int J Food Sci Nutr. 2021 May;72(3):293-299. doi: 10.1080/09637486.2020.1807475. Epub 2020 Aug 12.

  PMID: 32787470 BACKGROUND

• Doron S, Snydman DR. Risk and safety of probiotics. Clin Infect Dis. 2015 May 15;60 Suppl 2(Suppl 2):S129-34. doi: 10.1093/cid/civ085.

  PMID: 25922398 BACKGROUND

• Li KJ, Chen ZL, Huang Y, Zhang R, Luan XQ, Lei TT, Chen L. Dysbiosis of lower respiratory tract microbiome are associated with inflammation and microbial function variety. Respir Res. 2019 Dec 3;20(1):272. doi: 10.1186/s12931-019-1246-0.

  PMID: 31796027 BACKGROUND

• Xu K, Cai H, Shen Y, Ni Q, Chen Y, Hu S, Li J, Wang H, Yu L, Huang H, Qiu Y, Wei G, Fang Q, Zhou J, Sheng J, Liang T, Li L. [Management of COVID-19: the Zhejiang experience]. Zhejiang Da Xue Xue Bao Yi Xue Ban. 2020 Feb 21;49(2):147-157. doi: 10.3785/j.issn.1008-9292.2020.02.02. Chinese.

  PMID: 32391658 BACKGROUND

• Nguyen QV, Chong LC, Hor YY, Lew LC, Rather IA, Choi SB. Role of Probiotics in the Management of COVID-19: A Computational Perspective. Nutrients. 2022 Jan 10;14(2):274. doi: 10.3390/nu14020274.

  PMID: 35057455 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Petr Rysavka, Ph.D.

  Medi Pharma Vision

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 26, 2022
• Study Start: November 12, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2)