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Updated: Jun 4, 2026

Probiotic Studies in Neonatal Mice Using Gavage
Published on: January 27, 2019
Routine Lactobacillus rhamnosus GG administration in VLBW infants: a retrospective, 6-year cohort study
Paolo Manzoni1, Gianluca Lista, Elena Gallo
1Neonatology, S. Anna Hospital, Torino, Italy. paolomanzoni@hotmail.com
Insights
Routine use of Lactobacillus rhamnosus GG (LGG) probiotic in very low birth weight (VLBW) infants was safe and well-tolerated. This 6-year study found no adverse effects, demonstrating LGG
Area of Science:
- Neonatal Medicine
- Microbiology
- Pediatric Nutrition
Background:
- Probiotic use in preterm neonates is popular for preventing necrotizing enterocolitis (NEC), fungal colonization, and improving feeding tolerance.
- Concerns exist regarding the safety and tolerability of long-term probiotic administration in non-immunocompetent hosts.
- This study reports on the routine use of Lactobacillus rhamnosus GG (LGG) in very low birth weight (VLBW) infants over six years.
Purpose of the Study:
- To evaluate the safety and tolerability of routine Lactobacillus rhamnosus GG (LGG) supplementation in very low birth weight (VLBW) infants.
- To assess the microbiological safety and clinical outcomes associated with LGG administration.
- To analyze feeding tolerance and infection rates in VLBW infants receiving LGG.
Main Methods:
- Retrospective study of VLBW infants admitted to two Italian Neonatal Intensive Care Units (NICUs) from 2003-2008.
- Standard LGG administration: 3 x 10⁹ CFU/day orally for 4-6 weeks, starting on day 4 of life.
- Data collected included safety, tolerability, infections, feeding tolerance, and microbiological cultures.
Main Results:
- Complete data from 743 VLBW infants were analyzed; mean birth weight 1056g, mean gestational age 29.5 weeks.
- A total of 17,108 LGG doses were administered with no adverse effects or intolerances attributed to LGG.
- No LGG or other Lactobacilli were detected in over 5350 clinical and surveillance cultures; no LGG-attributable sepsis occurred. Fourteen NEC cases (1.9%) were reported.
Conclusions:
- Routine Lactobacillus rhamnosus GG (LGG) supplementation in a large cohort of VLBW infants is microbiologically safe.
- Clinical outcomes indicate that LGG is well-tolerated in this vulnerable population.
- The findings support the use of LGG as a safe probiotic intervention for VLBW infants.
Background:
In preterm neonates, use of probiotic mixtures is increasingly popular and is effective in preventing NEC, fungal colonization, and improving feeding tolerance. However, concerns exist about safety and tolerability of long-lasting administration of living microrganisms to not-immunocompetent hosts. We report a 6-year, two-NICUs experience of routinary Lactobacillus rhamnosus GG (LGG) use in VLBW infants.
Methods:
Clinical charts review, retrospective study of VLBW infants admitted to two Italian NICUs in the years 2003-2008. Standard protocol of LGG administration consisted of 3 x 10⁹ CFU/day, in single oral dose, since 4th day-of-life, for 4-to-6-week courses. Nutritional policy relied on administration of fresh, expressed mother's milk, supplementation with preterm formula if needed. Data about LGG safety and tolerability, infections, feeding tolerance, microbiological clinical and surveillance cultures were retrieved and analysed.
Results:
Complete data were obtained for 743 of 811 VLBW infants. Mean birth-weight was 1056 g; mean gestational age 29.5 weeks. A total of 17,108 LGG doses were administered (mean 23.1/infant). No adverse effects or intolerances putatively attributable to LGG occurred. Overall, 5350 clinical and surveillance cultures from 13 different sites/devices were performed (mean: 7.2 cultures from 6.5 different sites/infant). None ever grew LGG, or other Lactobacilli. No clinical sepsis episode was attributable to LGG. Full enteral feeding was achieved at 19.2 mean days-of-life; 73% of infants were exclusively/partially breastfed. Fourteen NEC cases occurred (=1.9%), with 5 (=0.7%) being>2b stage.
Conclusions:
Routinary supplementation of probiotic LGG in a large, 6-year VLBW infants Italian cohort proved microbiologically safe and clinically well tolerated.
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