Probiotics supplement in children with severe hand, foot, and mouth disease: A systematic review and meta-analysis protocol

BACKGROUND: Severe hand, foot, and mouth disease (HFMD) is an acute infectious disease caused by infection with serotypes of Enterovirus A, most commonly by enterovirus A71 and coxsackievirus A16. Clinical symptoms usually include fever, malaise, rashes on hands and feet, and oral vesicles. Of note, severe and even life-threatening complications can develop rapidly in young children, such as acute pulmonary edema, cardiopulmonary failure, aseptic meningitis, encephalitis and acute flaccid paralysis. Probiotics supplement have been demonstrated play a positive role as a therapeutic approaches for modulation of gut microbiota. This study aims to systematically investigate the efficacy and safety of probiotics for children with severe HFMD. METHODS: All randomized controlled trials related to probiotics and severe HFMD will be searched in 9 electronic databases (PubMed, Cochrane Library, Embase, ClinicalTrails, China National Knowledge Infrastructure, Sino Med, ScienceDirect, VIP, and Wanfang Data databases) from their inception to November 2019. The primary outcome is total effective rate, fever clearance time, rash regression time, remission time of neurological symptoms, and clinical cure time. Two researchers will perform the study selection, data extraction, and assessment of risk of bias independently. RevMan software (version 5.3) will be used for data synthesis. RESULTS: The findings of this study will be published in a peer-reviewed journal. CONCLUSION: The study will provide evidence to judge whether probiotics is an effective therapeutic intervention for severe HFMD. PROSPERO REGISTRATION NUMBER: PROSPERO CRD42019152946.