Effects of <i>Lactobacillus sporogenesis</i> on Pediatric Cholestatic Liver Disease: A Randomized, Triple-Blind, Placebo-Controlled Trial

Background: Recent studies have demonstrated the beneficial role of probiotics in liver disease in both children and adults, although only a limited number of studies have been conducted. This randomized, triple-blind, placebo‐controlled trial investigated the impact of Lactobacillus sporogenesis on children with cholestatic liver disease. Methods: Children with cholestatic liver disease and no prior use of probiotics were randomly divided into two groups. Fifteen drops of probiotics (L. sporogenesis) and placebo were administered daily to group A (intervention) and group B (placebo), respectively, for four weeks. Basic laboratory data and pediatric end-stage liver disease (PELD) scores were assessed at baseline and two weeks after completing the probiotic intervention. Results: Fifty-six children were enrolled and followed in group A (n = 28) and group B (n = 28), with biliary atresia and progressive familial intrahepatic cholestasis being the most common disease etiologies. No statistically significant difference was observed in PELD scores between the two groups before and after the intervention. However, PELD scores decreased in both groups following the intervention, with a significant reduction observed in group A (19.25 ± 9.20 vs. 15.27 ± 8.94) (P = 0.025). Albumin levels significantly decreased in group B (control) during follow-up, while prothrombin international normalized ratio (INR) levels significantly increased in both groups. Conclusions: A four-week trial of L. sporogenesis (probiotics) as a complementary nutritional support showed promising results. However, further studies with larger sample sizes are necessary to validate these findings.