Effect of a Multi-Strain Probiotic on the Incidence and Severity of Necrotizing Enterocolitis and Feeding Intolerances in Preterm Neonates
What this study found
NEC occurred in 0/100 neonates in the probiotic group vs 5/100 in placebo (p<0.001); Bell stages II/III occurred only in placebo (2 cases). Feeding intolerance developed in 14% with probiotic vs 35% with placebo (p<0.001; crude OR 0.19, adjusted OR 0.11). Time to full feeds shorter with probiotic (8.7 vs 9.7 days). Emesis and abdominal distension were reduced; days with NPO were fewer; total days of TPN not significantly different. Authors conclude LabinicTM is a safe and cost-effective approach to reducing NEC and feeding intolerance in preterm neonates <1500 g.
- Study & population
- Double-blind, placebo-controlled, randomized clinical trial at Tygerberg Hospital NICU; 200 preterm neonates (<37 weeks gestation) with birthweight 750–1500 g (100 per group); sexes included (probiotic: 47 male/53 female; placebo: 37 male/63 female); HIV-exposed: 22 vs 26; majority cesarean births; empiric antibiotics at birth; neonates followed from birth…
- Intervention
- LabinicTM multi-strain probiotic: Lactobacillus acidophilus 0.67 billion CFU; Bifidobacterium bifidum 0.67 billion CFU; Bifidobacterium infantis 0.67 billion CFU per day (total ~2.0 billion CFU).
- Key limitation
- High transfer-out rate reducing observation time; single-center; 28-day follow-up; no microbiome or cross-colonization assessments.
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Open PDFOriginal abstract
Background: Necrotizing enterocolitis (NEC) is a multifactorial disease, causing inflammation of the bowel. The exact root of NEC is still unknown, but a low weight and gestational age at birth are known causes. Furthermore, antibiotic use and abnormal bacterial colonization of the premature gut are possible causes. Premature neonates often experience feeding intolerances that disrupts the nutritional intake, leading to poor growth and neurodevelopmental impairment. Methods: We conducted a double-blind, placebo-controlled, randomized clinical trial to investigate the effect of a multi-strain probiotic formulation (LabinicTM) on the incidence and severity of NEC and feeding intolerances in preterm neonates. Results: There were five neonates in the placebo group who developed NEC (Stage 1A–3B), compared to no neonates in the probiotic group. Further, the use of probiotics showed a statistically significant reduction in the development of feeding intolerances, p < 0.001. Conclusion: A multi-strain probiotic is a safe and cost-effective way of preventing NEC and feeding intolerances in premature neonates.