A prospective case-control pilot study to evaluate the possible effect of a probiotic mixture in the improvement of symptoms, the reduction in the number of days of hospitalization and the increase in the percentage of patients with negative PCR after infection with the coronavirus SARS-CoV-2.
In this study, the investigators hypothesize a positive effect of probiotic on the gut microbiome that could led to produce a less severe clinical evolution of the disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Oral daily capsule containing probiotic strains with maltodextrin as excipient, administrated for 30 days.
Hospital Universitario del Vinalopó
Elche, Alicante, Spain
Hospital Universitario de Torrevieja
Torrevieja, Alicante, Spain
Cases with discharge to ICU.
Percentage of patients with discharge to ICU.
Time frame: 30-days
Patients with resolution of digestive symptoms
Percentage of patients with improvement between the initial and final visits
Time frame: 30 days
Patients with home discharge.
Percentage of patients with home discharge.
Time frame: 30-days
Mortality.
Percentage of deaths.
Time frame: 30-days
Treatment safety assessed by number of adverse events.
Number of adverse events that occur during the treatment period, attributable or not to the intervention product.
Time frame: 30-days
New cases of SARS-Cov-2 infection among healthcare personnel caring for the patients.
Number of new cases of positive SARS-Cov-2 infection by PCR analysis.
Time frame: 30-days
Patients with negative PCR and/or Antigen test result for SARS-CoV-2 infection.
Percentage of patients with negative test for SARS-CoV-2.
Time frame: 10-15 days
Patients with resolution of non-digestive symptoms
Percentage of patients with improvement between the initial and final visits
Time frame: 30 days
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