Placebo Controlled Introduction of Prophylactic Supplementation of Probiotics to Decrease the Incidence of Necrotizing Enterocolitis at Dhulikhel Hospital in Nepal.

Background Although recent reports suggest that the use of probiotics may enhance intestinal functions in premature infants, the mechanisms are unclear, and open questions remain regarding the safety and its efficacy. Objective The objective of this study is to evaluate the efficacy of probiotics on prevention of necrotizing enterocolitis in preterm infants in Nepal. Method We conducted a randomized, double blind, placebo controlled study of 72 hospitalized preterm infants. They were randomly allocated to receive probiotics (lactobacillus rhamnosus 35) at a dose of 0.8 mg in infants >1500 gms and 0.4 mg in infants <1500 gms in 2 ml of expressed breast milk two times daily or the same amount of expressed breast milk as placebo (without probiotics). Result Seventy-two patients were studied. The probiotics group (n=37) and placebo group (n=35) showed similar clinical characteristics. The incidence of necrotizing enterocolitis was found less frequently in the probiotic group (6/37, 16.2%) compared to the control group (10/35, 28.6%), this difference was not significant (p=0.16). This is 12.35% reduction in the incidence of necrotizing enterocolitis. Among the risk factors for necrotizing enterocolitis, pregnancy risk factors and perinatal risk factors were not significant. However neonatal risk factors were more frequent in the probiotic group (59.3%, n=32) than in the placebo group (40.7%, n=22), the difference was significant (p=0.02). Conclusion In the western world probiotics have been shown to be preventive in regard to necrotizing enterocolitis incidence. The present randomized trial showed a trend towards necrotizing enterocolitis minimal reduction in Nepal too. Further studies in a larger cohort are warranted to prove this effect for preterm infants.

RCT Entities:   Population Interventions Outcomes