Efficacy and Safety of Washed Microbiota Transplantation to Treat Patients with Mild-to-Severe COVID-19 and Suspected of Having Gut Microbiota Dysbiosis: Study Protocol for a Randomized Controlled Trial

Objective:Coronavirus disease 2019(COVTD-19)is often accompanied by gastrointestinal symptoms,which are related to gut microbiota dysbiosis(GMD).Whether washed microbiota transplantation(WMT)is an effective treatment for COV1D-19 patients suspected of having GMD by restoring the gut microbiota is unknown.This study is designed to explore the efficacy and safety of WMT in COVID-19 patients suspected of having GMD.Methods:This is a randomized,multicenter,single-blind prospective study.COVID-19 patients suspected of having GMD will be randomly divided to receive routine treatment only or to receive routine treatment and WMT.The frequency of WMT will be once a day for three consecutive days.Laboratory and imaging examinations will be performed at admission,1 and 2 weeks after treatment,and on the day of discharge.Then a telephone follow-up will be conducted at 1st week,2nd week,and 6th month after discharge.The clinical efficacy and safety of WMT in COVD-19 patients suspected of having GMD and the effects of WMT on the organ function,homeostasis,inflammatory response,intestinal mucosal barrier function,and immunity of the patients will be evaluated.Results:By following the proposed protocol,WMT is expected to be efficacious and safe for the treatment of COVID-19 patients suspected of having GMD,and the therapeutic effect is expected to be associated with improvement of the intestinal mucosal barrier function,inflammatory response,and immunity.Conclusion:The findings from this study may offer a new approach for the prevention and treatment of COVID-19 patients suspected of having GMD.