Comparison of the effect of ursodeoxycholic acid and multistrain synbiotic on indirect hyperbilirubinemia among neonates treated with phototherapy: A double-blind, randomized, placebo-controlled clinical trial study

BACKGROUND: This study was aimed at evaluating the effect of ursodeoxycholic acid (UDCA) and multistrain synbiotic on indirect hyperbilirubinemia among neonates treated with phototherapy. MATERIALS AND METHODS: This double-blind, randomized clinical trial was conducted on 120 subjects presenting with indirect hyperbilirubinemia in 2019. Subjects were randomly divided into three groups of synbiotic, UDCA, and control. The synbiotic group received five drops/day of synbiotic in addition to phototherapy. UDCA group received 10 mg/kg/day of Ursobil divided every 12 h in addition to phototherapy. The Control group received a placebo (water) in addition to phototherapy. Phototherapy was discontinued when the bilirubin levels reached <10 mg/dL. Total bilirubin levels were measured using the diazo method at 12, 24, and 36 h after hospitalization. This study used repeated measure analysis of variance and post hoc tests. RESULTS: The mean total of bilirubin was substantially decreased in both synbiotic and UDCA groups as compared to the control group at 24 h after hospitalization (P < 0.001). Moreover, the Bonferroni post hoc test showed significant differences regarding the mean total of bilirubin between the three groups (P < 0.05) except for the association between UDCA and synbiotic at 24 h after hospitalization (P > 0.99). CONCLUSION: Findings suggest that UDCA and synbiotic administration alongside phototherapy are more effective in reducing bilirubin levels as compared to phototherapy alone.