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Probiotic Studies in Neonatal Mice Using Gavage
Published on: January 27, 2019
Routine probiotic use in very preterm infants: retrospective comparison of two cohorts
Francesco Bonsante1, Silvia Iacobelli, Jean-Bernard Gouyon
1NICU, Department of Paediatrics, University of Dijon, France. fbonsante@yahoo.com
Insights
This study found that Lactobacillus rhamnosus Lcr35 (Lcr Restituo) significantly reduced necrotizing enterocolitis (NEC), mortality, and late-onset sepsis in very low-birth-weight infants. The probiotic was well-tolerated and improved feeding times.
Area of Science:
- Neonatal Medicine
- Microbiology
- Pediatric Gastroenterology
Background:
- Necrotizing enterocolitis (NEC) is a significant concern in very low-birth-weight infants.
- Probiotics have shown promise in reducing NEC, but routine use remains debated.
- A specific probiotic strain, Lactobacillus rhamnosus Lcr35 (Lcr Restituo), has been used as standard care in preterm infants since 2008.
Purpose of the Study:
- To evaluate the efficacy and safety of Lactobacillus rhamnosus Lcr35 (Lcr Restituo) in reducing NEC and other morbidities in preterm infants.
- To compare outcomes in a cohort of infants receiving probiotics with a historical control group.
Main Methods:
- A cohort study comparing infants receiving Lactobacillus rhamnosus Lcr35 (Lcr Restituo) (2 × 10^8 colony-forming units/12 h) with a historical cohort.
- Treatment was initiated early post-birth and continued up to 36 weeks' gestation.
- Primary outcome was definite NEC; secondary outcomes included mortality, late-onset sepsis (LOS), cholestasis, isolated rectal bleeding (IRB), and time to full enteral feeding (FEF).
Main Results:
- A total of 1130 infants were included; no adverse effects were reported.
- The probiotic cohort (PC) showed significantly reduced rates of NEC (OR 0.20), mortality (OR 0.46), and LOS (OR 0.60).
- Infants in the PC group achieved full enteral feeding (FEF) earlier, and isolated rectal bleeding (IRB) was significantly reduced with complete treatment.
Conclusions:
- Lactobacillus rhamnosus Lcr35 (Lcr Restituo) administration was well-tolerated in preterm infants.
- The probiotic was associated with lower rates of mortality and morbidities, including NEC, LOS, and IRB.
- Results support the use of this specific probiotic strain to improve outcomes in very low-birth-weight infants.
Objective:
Evidence supports the efficacy of probiotics in reducing necrotizing enterocolitis (NEC) in very low-birth-weight infants, although concerns remain with regard to their routine use. Since 2008 in our neonatal intensive care unit, a low dose of probiotics (unique strain) is administered as standard of care in all preterm babies born at 24 to 31 weeks' gestation. This study reports outcomes in infants receiving probiotic cohort (PC) compared with the historical cohort.
Design:
Treatment with Lactobacillus rhamnosus Lcr35 (Lcr Restituo) (2 × 108 colony-forming units/12 h) was started early after birth and intention to treat was up to 36 weeks' gestation. The main outcome was definite NEC. Secondary outcomes were mortality, late-onset sepsis (LOS), cholestasis, isolated rectal bleeding (IRB), and time to reach full enteral feeding (FEF).
Results:
A total of 1130 patients were included. No adverse effects were observed. Infants in PC presented a reduced rate of NEC (odds ratio [OR] 0.20; 95% confidence interval [CI] 0.07 to 0.58), mortality (OR 0.46; 95% CI 0.21 to 1.00), and LOS (OR 0.60; 95% CI 0.40 to 0.89) and achieved FEF significantly earlier. IRB was significantly reduced among infants receiving the complete scheduled treatment.
Conclusion:
Administration of Lcr Restituo was well tolerated and associated with lower mortality and morbidities in this cohort. Our results provide evidence in support of the hypothesis that this probiotic may reduce IRB.
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