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

• DOI: 10.1007/s11596-021-2475-2
• Publication Date: 2021-11-30T17:21:10Z
• Authors: Li-hao Wu; Zhi-ning Ye; Ping Peng; Wen-rui Xie; Jia-ting Xu; Xue-yuan Zhang; Harry Hua-xiang Xia; Xing-xiang He
• Keywords: Adult; Male; 0301 basic medicine; China; 0303 health sciences; SARS-CoV-2; COVID-19; Fecal Microbiota Transplantation; Middle Aged; Article; Gastrointestinal Microbiome; 3. Good health; Young Adult; 03 medical and health sciences; Treatment Outcome; Clinical Protocols; Living Donors; Dysbiosis; Humans; Female; Single-Blind Method; Prospective Studies; Safety; Aged

Coronavirus disease 2019 (COVID-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 COVID-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.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.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.The findings from this study may offer a new approach for the prevention and treatment of COVID-19 patients suspected of having GMD.