Efficacy Of Probiotics In Prevention Of Necrotizing Enterocolitis In Pre-Term Infants

Abstract

Background: Necrotizing enterocolitis (NEC) is a severe gastrointestinal disorder that predominantly affects pre-term neonates, contributing to high morbidity and mortality rates in this population. Objective: This study aims to assess the efficacy of Lactobacillus reuteri probiotics in preventing NEC in pre-term infants. Methods: A randomized controlled trial was conducted in the Neonatal Intensive Care Unit (NICU) of Fauji Foundation Hospital, Lahore, from 12th June 2024 to 12th July 2025. A total of 232 pre-term neonates with a gestational age of less than 36 weeks and 6 days were enrolled and randomly assigned to two groups: the study group (probiotics + breast milk, n = 116) and the control group (breast milk only, n = 116). Probiotics (Lactobacillus reuteri, 0.4 mL/5 drops, providing 100 million active cells) were administered once daily with breast milk from the first feeding.  Results: A total of 232 infants were enrolled, evenly divided between the two groups with comparable baseline characteristics. Probiotic supplementation significantly reduced gastrointestinal complications, with fewer cases of NEC (5.2% vs. 15.5%), feeding intolerance (8.6% vs. 19.0%), and positive stool occult blood (3.4% vs. 10.3%) compared to controls. The protective effect was most pronounced in infants born at <32 weeks, where NEC and occult blood positivity were markedly lower, while no probiotic-treated infant developed X-ray–confirmed NEC versus 0.8% in controls. Conclusions: This study concludes that Lactobacillus reuteri probiotics are effective in reducing the incidence of NEC and related complications in pre-term neonates. The findings support the use of probiotics as a preventive intervention in the NICU setting. Further research is needed to explore the long-term effects and optimal probiotic strains for preventing NEC in pre-term infants.