Trial design
RRMS
This study was conducted as a 4-month prospective randomized double-blinded clinical trial among patients with a documented diagnosis of Relapsing–remitting MS (RRMS) referred to outpatient specialized and subspecialty clinics of Emam Reza Hospital of Tabriz University of Medical Sciences From June 2021 to March 2022 following the consolidated standards of reporting trials (CONSORT) guidelines. The eligible patients were randomly assigned to probiotic or placebo groups after a two-week wash-out period, with a 1:1 allocation ratio after baseline assessment. During the washing phase, patients were instructed to refrain from consuming probiotics such as yogurts with live active cultures, supplements, or any other dietary supplement, except for vitamin D3. The detailed trial protocol of the present study has been previously publishedThe trial was reviewed and approved by the ethics committee of the Research Vice-Chancellor of Tabriz University of Medical Sciences (IR.TBZMED.REC.1396.59) and was registered with the Iranian Clinical Trial Registry (IRCT20161022030424N1, 09/04/2018). Before any procedures were performed, we obtained written informed consent from all patients. Furthermore, we analyzed all data anonymously to ensure confidentiality.