IRCT2012071410279N1 IRCT 2012-10-19 Health Ministry Drug and Pharmacy General Management Outcome of Saccharomyces boulardii prophlaxis on necrotizing enterocolitis Comparison of prophylaxis effect of Saccharomyces boulardii on necrotizing enterocolitis with placebo on very low birth weight infants 2010-10-01 anticipated 208 Complete https://irct.ir/trial/10741 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: Patients were assigned randomly to the study or control group by the principal investigator. Randomization was performed by using sequential numbers generated at the computer center. Feeding nurse who was not involved in the care of the infants added Saccharomyces boulardii to the feeding. She gave the feeding without label to the nurse who was responsible from the infant’s care. The first investigator who randomized patients and ordered supplementation to the feeding nurse gave just only the patients name to the second investigator for follow-up. Therefore, the only personnel who knew the infants’ group assignments were the first investigator and the feeding nurse, who were not involved in the care of the study infants. 3 Necrotizing eneterocolitis, neonatal sepsis. Intervention 1: The study group received Saccharomyces boulardii (Reflor®, Biocodex, France, 50 mg/kg per dose twice daily) which were added to breast milk or formula until discharge. Intervention 2: The control group received placebo (distilled water; 1 cc per dose twice daily) which were added to breast milk or formula until discharge.