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An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic strain on the immune response in participants positive for SARS-CoV-2 infection.
The study duration will be 28 days, which includes 4 weeks product administration. Participants will be randomized assigned to one of the two study groups: the control group with placebo consumption and a probiotic consumption group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic: Lactobacillus salivarius + Vit D + Zinc | Active Comparator | Lactobacillus strain during 28 days, approximately 1*10E9 colony forming unit (CFU) of L. salivarius in 1 capsule per day. |
|
| Placebo | Placebo Comparator | Placebo supplement in 1 capsule per day during 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic: Lactobacillus salivarius + Vit D + Zinc | Dietary Supplement | A mixture of 1*10E9 colony forming unit (CFU) of Lactobacillus salivarius + Vit D + Zinc citrate in 1 capsule will be daily administrated during 28 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of specific IgM (Immunoglobulin M) and IgG (Immunoglobulin G) antibodies for the SARS-CoV-2 virus. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Levels (pg/ml) of pro-inflammatory and anti-inflammatory markers in blood serum. | 1 month | |
| Duration of the symptoms produced by the SARS-CoV-2 infection | 1 month | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Infanta Leonor | Madrid | Spain |
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| Label | URL |
|---|---|
| Related Info | View source |
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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 |
|---|---|
| D015032 | Zinc |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
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| Placebo | Dietary Supplement | Placebo in 1 capsule will be daily administrated during 28 days. |
|
| Severity of symptoms produced during SARS-CoV-2 infection |
Severity of symtoms will be analysed for fever (Tª>38ºC) and gastrointestinal symptons (Bristol scale). |
| 1 month |
| Percentage of participants with a negative result in the SARS-CoV-2 detection test by PCR (Polymerase Chain Reaction) at visit 2 | 1 month |
| Percentage of participants with worsening of lower respiratory tract infections | 1 month |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008670 |
| Metals |