Metabolic dysfunction-associated fatty liver disease (MAFLD) has become one of the most prevalent chronic liver diseases worldwide and represents a major public health challenge. It is estimated that nearly 30% of the global adult population is affected, making MAFLD one of the fastest-growing causes of chronic liver disease and liver-related complications. The increasing prevalence of obesity, insulin resistance and type 2 diabetes continues to drive this global epidemic.

Obesity is one of the strongest risk factors for MAFLD. Current evidence indicates that approximately 70–90% of individuals with obesity develop hepatic steatosis, while many also present metabolic abnormalities including dyslipidemia, impaired glucose metabolism and chronic low-grade inflammation. If left untreated, MAFLD may progress to steatohepatitis, fibrosis, cirrhosis and hepatocellular carcinoma, while simultaneously increasing cardiovascular and metabolic risk.

Despite its high prevalence, therapeutic options remain limited. Current management primarily focuses on lifestyle modification through dietary intervention, weight reduction and increased physical activity. Although these measures remain the cornerstone of treatment, long-term adherence is often poor, highlighting the need for complementary therapeutic strategies capable of targeting the underlying mechanisms involved in metabolic dysfunction and gut microbiota alterations.

Increasing evidence supports the critical role of the gut microbiota in the development and progression of MAFLD. Alterations in microbial composition and function contribute to intestinal permeability, systemic inflammation, insulin resistance and disrupted lipid metabolism through the gut–liver axis. Consequently, microbiota-targeted interventions have emerged as a promising therapeutic approach for metabolic diseases.

Metabiotics® represent an innovative evolution of microbiota-based therapeutics by integrating prebiotics, probiotics and bioactive postbiotic compounds into a single formulation designed to modulate the gut ecosystem and its metabolic activity. This next-generation strategy aims to provide a more precise and functionally targeted approach than conventional probiotic supplementation.

To explore the clinical potential of this concept, the present randomized, double-blind, placebo-controlled clinical trial evaluated the safety and effectiveness of a Metabiotic® formulation in adults with MAFLD and grade I obesity. The study demonstrated significant improvements in liver function, glycemic control, insulin sensitivity, lipid profile and gut hormone regulation after 12 weeks of intervention, while maintaining a favorable safety profile.