The Role of VSL#3® in the Treatment of Fatigue and Other Symptoms in Long Covid-19 Syndrome: a Randomized, Double-blind, Placebo-controlled Pilot Study (DELong#3)

Abstract

AbstractLong COVID, also known as Post-acute COVID-19 Syndrome (PACS), is a chronic condition affecting individuals who have recovered from acute COVID-19. It is currently estimated that around 65 million people worldwide suffer from Long COVID. It is characterized by a range of symptoms, including fatigue, exertion intolerance, neurocognitive and sensory impairment, sleep disturbance, myalgia/arthralgia, and dysautonomia. Among them fatigue has emerged as a burdensome and pervasive issue, significantly impacting the quality of life and daily functioning of Long COVID patients. Alterations in the composition of the intestinal microbiota has been reported in COVID-19 patients. Dysbiosis persists even after several months of recovery from acute SARS-CoV-2 infection.Based on this evidence, we carried out a phase 3, randomized, double-blind, placebo-controlled trial aimed at evaluating the efficacy of VSL#3®, a consortium of probiotic bacterial strains, in reducing fatigue and improving various aspects of patients’ well-being in patients with Long COVID syndrome.HighlightsPatients suffering from Long-COVID manifest a variety of persistent symptoms impacting daily functioning;Fatigue emerged as a burdensome and pervasive issue, significantly impacting the quality of life;VSL#3® treatment significantly reduced the Chalder Fatigue Scale scores as compared to placeboChalder Fatigue Scale scores remained significantly reduced in the treatment group 4 weeks post intervention.