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Author Notes:

Corresponding author and reprint requests: Ravi Mangal Patel, MD, MSc, 2015 Uppergate Dr. NE, 3rd floor, Division of Neonatology, Emory University School of Medicine, Atlanta, GA 30322. rmpatel@emory.edu; Tel: (404) 727-5905; Fax: (404) 727-3236.

The other authors declare no conflicts of interest.


Research Funding:

Emory University received a research grant from the Gerber Foundation (to A.S.).

P.D. was supported by the National Institutes of Health (NIH) (R01 HD059122).

R.P. was supported by the NIH (KL2 TR000455, UL1 TR000454, and K23 HL128942), received honorarium and travel support from Mednax, Inc, and is a consultant for Shipman & Goodwin, LLC.

A.S. received travel support from the International Scientific Association of Probiotics and Prebiotics and received an unrestricted donation of probiotic and placebo products for an unrelated research study in 2010.


  • Science & Technology
  • Life Sciences & Biomedicine
  • Pediatrics

Routine Supplementation of Lactobacillus rhamnosus GG and Risk of Necrotizing Enterocolitis in Very Low Birth Weight Infants


Journal Title:

Journal of Pediatrics


Volume 195


, Pages 73-+

Type of Work:

Article | Post-print: After Peer Review


Objective: To evaluate if routine supplementation of Lactobacillus rhamnosus GG ATCC 53103 (LGG) is associated with a decreased risk of necrotizing enterocolitis in very low birth weight (VLBW) infants. Study design: Retrospective observational cohort study of VLBW (<1500 g) infants at a single center from 2008 to 2016. LGG supplementation with Culturelle at a dose of 2.5 to 5 × 10 9 CFU/day began in 2014. We used multivariable logistic regression to evaluate the association between LGG supplementation and necrotizing enterocolitis (modified Bell stage IIA or greater), after adjusting for potential confounders. We also compared changes in necrotizing enterocolitis incidence before and after implementation of LGG using a statistical process control chart. Results: We evaluated 640 VLBW infants with a median gestational age of 28.7 weeks (IQR 26.3-30.6); 78 (12%) developed necrotizing enterocolitis. The median age at first dose of LGG was 6 days (IQR 3-10), and duration of supplementation was 32 days (IQR 18-45). The incidence of necrotizing enterocolitis in the epoch before LGG implementation was 10.2% compared with 16.8% after implementation. In multivariable analysis, LGG supplementation was associated with a higher risk of necrotizing enterocolitis (aOR 2.10, 95 % CI 1.25-3.54, P =.005). We found no special cause variation in necrotizing enterocolitis after implementation of LGG supplementation. There were no episodes of Lactobacillus sepsis during 5558 infant days of LGG supplementation. Conclusions: In this study, routine LGG supplementation was not associated with a decreased risk of necrotizing enterocolitis. Our findings do not support the use of the most common probiotic preparation currently supplemented to VLBW infants in the US.

Copyright information:

© 2017 Elsevier Inc.

This is an Open Access work distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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