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The aim of the present study is to evaluate the effects of Lactobacillus coryniformis K8 consumption on the incidence and severity of Covid-19 in health workers exposed to the virus. This is a preventive study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | Experimental group who will receive one capsule of Lactobacillus K8 per day (3x10^9 cfu/day). |
|
| Control | Placebo Comparator | Control group who will receive a daily placebo capsule consisting of maltodextrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | The probiotic group will received one capsule with Lactobacillus K8 per day (3x10^9 cfu/day) during 2 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of SARS CoV-2 infection in healthcare workers | The incidence of SARS CoV-2 infection will be confirmed by PCR or antigen test | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hospital admissions caused by SARS-CoV-2 infection | In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), it will be evaluated how many of them will required hospital admission because of Covid-19 | 8 weeks |
| Incidence of ICU admissions caused by SARS-CoV-2 infection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raquel Rodriguez Blanque | Contact | +34 958 023 000 | raquel.rodriguez.blanque.sspa@juntadeandalucia.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raquel Rodriguez Blanque | Recruiting | Granada | 18016 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37285326 | Derived | Rodriguez-Blanque R, Sanchez-Garcia JC, Cobos Vargas A, Leyva Martinez MS, Martinez Diz S, Cortes-Martin J, Tovar-Galvez MI. Evaluation of Lactobacillus Coryniformis K8 Consumption by Health Care Workers Exposed to COVID-19 (LactoCor2 Project): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Jun 28;12:e37857. doi: 10.2196/37857. |
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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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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Control | Dietary Supplement | The control group will received one placebo capsule per day during 2 months |
|
In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), it will be evaluated how many of them will required ICU admission because of Covid-19 |
| 8 weeks |
| Incidence of pneumonia caused by SARS-CoV-2 infection | In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), it will be evaluated how many of them will develop pneumonia because of Covid-19 | 8 weeks |
| Incidence of oxygen support requirement caused by SARS-CoV-2 infection | In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), it will be evaluated how many of them will require oxygen support because of Covid-19 | 8 weeks |
| Incidence of gastrointestinal symptoms caused by SARS-CoV-2 infection | In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), it will be evaluated how many of them will develop gastrointestinal symptoms because of Covid-19 | 8 weeks |
| Days with body's temperature > 37.5 ºC | In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), number of days with body's temperature > 37.5 ºC during the course of the disease | 8 weeks |
| Days with cough | In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), number of days with cough during the course of the disease | 8 weeks |
| Days with fatigue | In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), number of days with fatigue during the course of the disease | 8 weeks |
| Medical treatment | Use of drugs (dosis and duration of the treatment) for Covid-19 treatment | 8 weeks |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D019602 |
| Food and Beverages |