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. 2021 Nov 30;41(6):1087–1095. doi: 10.1007/s11596-021-2475-2

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 1,2,#, Zhi-ning Ye 1,2,#, Ping Peng 3, Wen-rui Xie 1,2, Jia-ting Xu 1,2, Xue-yuan Zhang 1,2, Harry Hua-xiang Xia 1, Xing-xiang He 1,2,✉
PMCID: PMC8630278  PMID: 34846698

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.

Electronic supplementary material

The online version of this article (10.1007/s11596-021-2475-2) contains supplementary material, which is available to authorized users.

Key words: COVID-19, SARS-Cov-2 virus, gut microbiota, microbiome, dysbiosis, washed microbiota transplantation

Electronic Supplementary Material

11596_2021_2475_MOESM1_ESM.pdf (220.9KB, pdf)

Supplementary material, approximately 240 KB.

Acknowledgments

We thank Dr. Tao LIU for his help with the Statistical Analysis section of this article.

Footnotes

This study was supported by the Special Research Project on Prevention and Control of COVID-19 in Universities of the Guangdong Provincial Education Department (No. 2020KZDZX1132).

Conflict of Interest Statement

All authors have no conflict of interest in this study.

Li-hao WU and Zhi-ning YE contributed equally to this work.

Contributor Information

Li-hao Wu, Email: wulihao888@126.com.

Zhi-ning Ye, Email: 1554520250@qq.com.

Xing-xiang He, Email: hexingxiang@gdpu.edu.cn.

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Associated Data

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Supplementary Materials

11596_2021_2475_MOESM1_ESM.pdf (220.9KB, pdf)

Supplementary material, approximately 240 KB.

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