Short term synbiotic supplementation improves hepatic and metabolic outcomes in children with metabolic dysfunction...

Metabolic dysfunction-associated steatotic liver disease (MASLD) is an increasingly recognized chronic liver disorder in children and adolescents, particularly among those with obesity and insulin resistance. Given the emerging role of the gut-liver axis in disease pathogenesis, this study aimed to evaluate the effectiveness of synbiotic supplementation in improving biochemical and ultrasonographic outcomes in pediatric MASLD. This double-blind, randomized, placebo-controlled clinical trial was conducted over 8 weeks. A total of 60 participants aged 10-18 years with MASLD were randomly assigned to receive either synbiotics (n = 30) or placebo (n = 30). The synbiotic formulation contained a combination of nine probiotic strains with a prebiotic component, whereas the placebo consisted of prebiotic-only capsules (fructooligosaccharide with sucrose). The primary outcomes were predefined as changes in liver enzyme activities (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) and hepatic steatosis grade assessed by ultrasonography, while secondary outcomes included body mass index (BMI) and lipid profile parameters. Between-group differences were analyzed using appropriate statistical models adjusting for baseline values. After 8 weeks, the synbiotics group showed statistically significant reductions in BMI (- 0.70 ± 0.16 kg/m²), triglycerides (- 10.50 ± 3.10 mg/dL), total cholesterol (- 10.50 ± 2.90 mg/dL), and LDL-cholesterol (- 5.46 ± 1.85 mg/dL) compared with the placebo group (all p < 0.001). Liver enzyme activities decreased significantly in the synbiotics group (ALT - 20.36 ± 7.18 U/L; AST - 16.76 ± 10.67 U/L), with greater reductions than in the placebo group (p < 0.001 for between-group comparisons). Furthermore, improvement in hepatic steatosis grade was observed in 73.3% of participants in the synbiotics group compared to 23.3% in the placebo group (p < 0.001). Synbiotic supplementation over an 8-week period was associated with significant improvements in liver enzyme activities, lipid profile, BMI, and ultrasonographic steatosis grade in children with MASLD. While these findings suggest a beneficial role for synbiotics as an adjunctive strategy, the relatively short intervention period and lack of control for lifestyle factors warrant cautious interpretation. Further studies with longer follow-up, detailed lifestyle assessment, and mechanistic investigations are needed to confirm these results and clarify the underlying pathways.Iranian Registry of Clinical Trials code: IRCT20220314054279N1.