ProSci-246 with dietary guidance alters gut microbiota and metabolism in childhood obesity: a randomized trial

Childhood obesity remains a pressing global health challenge with few effective therapeutic strategies. This study combined a cross-sectional analysis of 99 children (49 obese, 50 healthy) with a 3-month, randomized, double-blind, placebo-controlled trial in 95 children with obesity to investigate the role of gut microbiota in pediatric obesity and evaluate Bifidobacterium animalis subsp. lactis ProSci-246 as a microbiota-targeted intervention. In the intervention phase, ProSci-246 combined with personalized dietary counseling was associated with greater body mass index (BMI) reduction at 3 months ( P = 0.049, q = 0.058) and showed a trend toward accelerated fat loss at 1 month ( P = 0.035, q = 0.093), while serum uric acid was lower in the active group at 2–3 months ( P = 0.032, q < 0.05). Multi-omics profiling revealed that ProSci-246 induced targeted microbial remodeling, enriching beneficial taxa ( Bifidobacterium animalis , Lactiplantibacillus plantarum , Blautia spp.) and depleting Faecalibacterium duncaniae , and functionally shifted metabolism toward starch utilization, increased TCA cycle intermediates, promoted bile acid conversion, and normalized arginine metabolism. Fecal lactate was negatively correlated with BMI; taurocholic acid was positively correlated with uric acid. These findings suggest that ProSci-246 remodels gut microbial ecology and metabolic output in childhood obesity, offering a potential complementary approach. Results are exploratory and require validation in larger confirmatory trials.