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| Name | Class |
|---|---|
| Veterinary Research Institute | UNKNOWN |
| Brno University Hospital | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum | Experimental | Patients received probiotic supplement SmartProbio C, one capsule twice a day - mornings and evenings before meal - for a period of 2 weeks. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospitalisation | 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). | From the date of admission to hospital until discharge from hospital or above defined two point improvement, whichever comes first |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Petr Rysavka, Ph.D. | Medi Pharma Vision | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medi Pharma Vision | Brno | 61200 | Czechia | |||
| Brno University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30099133 | Background | 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. | |
| 32574290 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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|
| Placebo | Dietary Supplement | Placebo. HPMC (hydroxypropylmethylcelulose) capsule filled with maltodextrin. Dosage twice a day. |
|
| Monitoring the length of oxygen dependence | Measurement of the time it was necessary to provide HFOT (high flow oxygen therapy) to the patient | 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 | Monitoring of laboratory marker of inflammation - serum peripheral blood CRP levels | On the first day of admission to hospital and on the day of hospital discharge, but no later than 14th day |
| Monitoring mortality rates | The percentage of deaths in the placebo group compared to percentage of deaths in the verum group | From the date of admission to hospital until discharge from hospital or death, whichever comes first |
| Brno |
| 62500 |
| Czechia |
| 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. |
| 32787470 | 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. |
| 25922398 | 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. |
| 31796027 | 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. |
| 32391658 | 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. |
| 35057455 | 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |