Randomized controlled trial to study the safety and efficacy of probiotics supplementation in addition to the standard treatment in novel coronavirus (SARS‑CoV‑2) positive patients

Abstract

Background: The severe acute respiratory syndrome-related coronavirus-2 (SARS-CoV-2) infection spread at a catastrophic rate, rapidly becoming a pandemic. Apart from the symptoms related to viral infection, a few patients with Coronavirus Disease 2019 (COVID-19) also experienced gastrointestinal symptoms. There was initial evidence of intestinal microbial dysbiosis in COVID-19 cases, and a few international studies showed the benefits of probiotics in reducing gastrointestinal (GI) symptoms and favorably altering the course of COVID-19 disease. Aims and Objectives: This study was planned to investigate if probiotics show any beneficial effects on COVID-19 disease in Indian patients. Materials and Methods: A prospective, randomized, open-label study was conducted to evaluate the effect of probiotic supplements added to the existing standard treatment in patients with the novel coronavirus SARS-CoV2 and compared them with the control group. Ninety patients were included in this study and were observed on day 1, day 3, day 5, day 10, day 14, and day of discharge for progression or recovery. Patients were monitored for symptom progression, the need for oxygen therapy, ventilation needs, etc. Results: There was no significant difference in the parameters at baseline in either of the groups. Cough was significantly less in group A (the standard control group) compared to group B (the probiotic group) only on day 5. No significant difference in the number of patients with coughs was seen on the other days. Other important parameters were not significantly different on any day of observation. Conclusion: The study results do not support the use of probiotics for the treatment of GI symptoms related to COVID19 and do not alter the course of COVID-19 disease or symptoms so as to be used as adjunct therapy for COVID-19 patients.