Evaluation of safety and effectiveness of a metabiotic product in patients with metabolic dysfunction-associated fatty liver disease with obesity grade I

Metabolic dysfunction-associated fatty liver disease (MAFLD) and obesity are clearly correlated with intestinal dysbiosis. Traditional probiotics have been used as adjuvants in the treatment of MAFDL and obesity, yielding inconsistent results; however, their effectiveness and safety have not yet been demonstrated. Recently, metabiotics have emerged as a new generation of probiotics offering a potential safe and effective strategy for managing metabolic disorders. This study aimed to evaluate the safety and effectiveness of a novel metabiotic formulation containing prebiotics, probiotics, and bioactive postbiotic compounds. We conducted a 12-week randomized, double-blinded, placebo-controlled clinical trial in patients diagnosed with MAFLD and obesity grade I. A total of 50 patients were enrolled and monitored for treatment adherence and adverse events. Clinical Assessments, including physical examination, body weight measurements, and biochemical analyses, were performed at the beginning and at the end of the treatment regimen. Significant differences were observed in liver function markers, lipid and glycemic profiles, and the release of key hormones involved in obesity. The intervention was well tolerated, with only mild, transient flatulence reported in 3 patients. In conclusion, this Metabiotic formulation showed to be a promising, safe and effective therapeutic strategy as adjuvant in the treatment of patients with MAFDL and obesity grade I, even in the absence of dietary or physical activity modifications. Key words. Metabiotics, postbiotics, next-generation probiotics, metabolic disease adjuvant, metabolic dysfunction-associated fatty liver disease.