Efficacy of Bifidobacterium Animalis Subsp. Lactis in the Treatment of Indirect Hyperbilirubinemia in Term Neonates

Eligible term neonates with indirect hyperbilirubinemia requiring phototherapy will be randomly assigned to either the intervention group or the control group.

Neonates in the intervention group will receive oral Bifidobacterium animalis subsp. lactis (1 × 10⁹ CFU/day) in addition to standard phototherapy from the initiation of phototherapy until its discontinuation.

Neonates in the control group will receive standard phototherapy alone according to the hospital protocol.

All participants will undergo clinical evaluation and serum total bilirubin measurement before treatment and at day 3 of phototherapy. During hospitalization, the duration of phototherapy, length of hospital stay, serum bilirubin levels, and phototherapy-related adverse events will be recorded. Hospital readmission, including the occurrence, number, and primary reason for readmission, will be assessed at 28 days, 3 months, and 6 months of age.

Inclusion criteria

• Age from 0-28 days.
• Gestational age 37-42 weeks.
• Diagnosed with indirect hyperbilirubinemia according to the AAP 2022 guidelines.
• Eligible for phototherapy based on serum total bilirubin levels
• Informed consent obtained from a parent or legal guardian.

Exclusion criteria

• Direct hyperbilirubinemia (direct bilirubin >2.0 mg/dL and >20% of total serum bilirubin).
• Major congenital anomalies or severe concurrent illness (e.g., respiratory failure, intracranial hemorrhage).
• Indication for exchange transfusion, intravenous immunoglobulin (IVIG) or phenobarbital according to the AAP 2022 guidelines.
• Neonatal sepsis, blood group incompatibility, glucose-6-phosphate dehydrogenase deficiency, red blood cell membrane disorders.
• Suspected gastrointestinal obstruction.
• Unable to tolerate oral feeding.