tetano
Editor, Senior Moderator
- Curr Med Sci
- . 2021 Nov 30;1-9.
- doi: 10.1007/s11596-021-2475-2. Online ahead of print.
- 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
Li-Hao Wu[SUP] #[/SUP][SUP] 1 2 [/SUP], Zhi-Ning Ye[SUP] #[/SUP][SUP] 1 2 [/SUP], Ping Peng[SUP] 3 [/SUP], Wen-Rui Xie[SUP] 1 2 [/SUP], Jia-Ting Xu[SUP] 1 2 [/SUP], Xue-Yuan Zhang[SUP] 1 2 [/SUP], Harry Hua-Xiang Xia[SUP] 1 [/SUP], Xing-Xiang He[SUP] 4 5 [/SUP]
Affiliations
- PMID: 34846698
- PMCID: PMC8630278
- DOI: 10.1007/s11596-021-2475-2
Abstract
Objective: 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.
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.
Keywords: COVID-19; SARS-Cov-2 virus; dysbiosis; gut microbiota; microbiome; washed microbiota transplantation.