多株複合型シンバイオティクスとライフスタイル改善が代謝機能不全関連脂肪性肝疾患（MASLD）患者に与える影響：ランダム化二重盲検プラセボ対照試験

MASLD is the most common chronic liver disease and the leading cause of liver-related morbidity and mortality globally. While probiotic supplementations show promise as adjunctive therapy, existing trials are limited by the quality of evidence, small sample sizes, and methodological inconsistencies, highlighting the need for well-designed studies, particularly on multi-strain synbiotics. Therefore, we conducted this trial to evaluate the effects of multi-strain synbiotic combined with lifestyle modifications, including an individualized diet and physical activity program, on patients with MASLD.

In this randomized, double-blinded, placebo-controlled trial, 80 MASLD patients were enrolled and underwent lifestyle modifications. Participants were randomized in a 1:1 ratio to receive either synbiotic capsules (500 mg each, 10⁹ CFU per capsule) containing two strains of Bifidobacteria, two strains of Lacticaseibacillus, two strains of Lactobacillus, and one strain of Streptococcus, as well as Fructooligosaccharides as prebiotic, or placebo (one capsule every 12 h) for 12 weeks. All patients were evaluated both at the beginning and the end of the trial in terms of anthropometric parameters (weight, BMI, and WC), hematological parameters (Hb and Plt), coagulation status (PT and INR), lipid profile (TG, TC, HDL-C, and LDL-C), FBS, liver function (ALT and AST), and liver inflammatory biomarkers (TNF-α and IL-6).

No significant changes were observed in anthropometric measures either within or between groups during the study period. Moreover, analysis of venous blood samples at the end of the trial showed significant improvements in some measures of lipid profile (TC and LDL-C), FBS, liver function (ALT and AST), and liver inflammatory biomarkers (TNF-α and IL-6) in the synbiotics-receiving group compared to both the beginning of the trial and the placebo-receiving group. However, no significant changes were observed in hematological parameters (Hb and Plt), coagulation status (PT and INR), and lipid profile (TG and HDL-C) compared to the beginning of the trial and the placebo-receiving group. Supplements were tolerated well, with no complications or allergic reactions reported.

Supplementation with multi-strain synbiotics, in combination with lifestyle modifications, could serve as a promising adjunctive therapy to control disease progression in patients with MASLD.