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Войти в исследования Efficacy and safety of microbiota-targeted therapeutics in autoimmune and inflammatory rheumatic diseases: protocol for a systematic review and meta-analysis of randomised controlled trials.
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Kragsnaes Maja Skov, Gilbert Benoit Thomas P, Sofíudóttir Bjørk Khaliqi, Rooney Christopher Michael, Hansen Sebrina Maj-Britt, Mauro Daniele, Mullish Benjamin H, Bergot Anne-Sophie, Mankia Kulveer Singh, Goel Niti, Bakland Gunnstein, Johnsen Peter Holger, Miguens Blanco Jesus, Li Simone, Dumas Emilie, Lage-Hansen Philip Rask, Wagenaar Carlijn, Bakdash Ghaith, Robinson Mat, Kristiansen Karsten, Marchesi Julian R, Schett Georg, Zaiss Mario M, Orlu Mine, van Schaadenburg Dirkjan, Scher Jose U, McGonagle Dennis, Elewaut Dirk, Breban Maxime, Tugwell Peter, Finckh Axel, Ciccia Francesco, Kriegel Martin A, Daien Claire, Ellingsen Torkell, Christensen Robin, EULAR Study Group MICMUC
Аннотация
METHODS AND ANALYSIS: This protocol used the reporting guidelines from the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocol. We will search Embase (Ovid), Medline (Ovid) and the Cochrane Library (Central) for reports of randomised controlled trials of patients diagnosed with an AIRD. Eligible interventions are therapies targeting the intestinal microbiota and/or gut barrier function including probiotics, synbiotics, faecal microbiota transplantation, live biotherapeutic products and antibiotics with the intent to modify disease activity in AIRDs. The primary outcome of the evidence synthesis will be based on the primary endpoint of each trial. Secondary efficacy outcomes will be evaluated and selected from the existing core domain sets of the individual diseases and include the following domains: disease control, patient global assessment, physician global assessment, health-related quality of life, fatigue, pain and inflammation. Harms will include the total number of withdrawals, withdrawals due to adverse events, number of patients with serious adverse events, disease flares and deaths. A meta-analysis will be performed for each outcome domain separately. Depending on the type of outcome, the quantitative synthesis will encompass both ORs and standardised mean differences with corresponding 95% CIs.
ETHICS AND DISSEMINATION: No ethics approval will be needed for this systematic review. We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to disseminate the study results through a peer-reviewed publication.
PROSPERO REGISTRATION NUMBER: CRD42025644244.