• Shixiong Zhang, Jingjing Lv, Xuetong Ren, Xinyu Hao, Pingping Zhou, and Yangang Wang.
• Hebei University of Chinese Medicine.
• Medicine (Baltimore). 2020 Jul 10; 99 (28): e21267.

BackgroundSystemic sclerosis (SSc) is 1 of the most complex systemic autoimmune diseases.Accumulating evidence suggests that gut microbiota affect the development and function of the immune system and may play a role in the pathogenesis of autoimmune diseases. This new paradigm raises the possibility that many diseases result, at least partially, from microbiota-related dysfunction. This understanding invites the investigation of fecal microbiota transplantation (FMT) in the treatment of SSc. However, no study has specifically and systematically investigated the efficacy and safety of FMT in the treatment of SSc. Thus, this study will systematically and comprehensively appraise the efficacy and safety of FMT in the treatment of SSc.MethodsWe will search the following sources without restrictions for date, language, or publication status: PubMed, Web of Science,Cochrane Central Register of Controlled Trials (CENTRAL) Cochrane Library, EMBASE and China National Knowledge Infrastructure. We will apply a combination of Medical Subject Heading (MeSH) and free-text terms incorporating database-specific controlled vocabularies and text words to implement search strategies. We will also search the ongoing trials registered in the World Health Organization's International Clinical Trials Registry Platform. Besides, the previous relevant reviews conducted on FMT for SSc and reference lists of included studies will also be searched.ResultsThis study will provide a reliable basis for the treatment of SSc with FMT.ConclusionsThe findings will be an available reference to evaluate the efficacy and safety of FMT in the treatment of SSc.Registration NumberINPLASY202060019.

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