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Updated: Oct 2, 2025

Probiotic Studies in Neonatal Mice Using Gavage
Published on: January 27, 2019
Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effect of Two Probiotics on the Preterms' Gut
Bárbara Moreno-Sanz1,2, María Teresa Montes1,2, Susana Manzano3
1Department of Neonatology, La Paz University Hospital.
Insights
This study found that a new probiotic combination, Ligilactobacillus salivarius subsp infantis PS11603 and Bifidobacterium longum PS10402, significantly enhanced gut bacterial colonization in preterm infants. The probiotic group showed earlier and more robust colonization of Lactobacillus and Bifidobacterium species.
Area of Science:
- Microbiology
- Neonatal Research
- Gastroenterology
Background:
- Preterm infants often experience delayed gut microbiota colonization, increasing susceptibility to infections.
- Early gut colonization is crucial for immune system development and overall infant health.
Purpose of the Study:
- To evaluate the efficacy of a novel probiotic combination (Ligilactobacillus salivarius subsp infantis PS11603 and Bifidobacterium longum PS10402) in promoting gut bacterial colonization in preterm infants.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 30 preterm infants.
- Stool sample analysis using classical microbiology and metagenomics.
- Assessment of bacterial and immune profiles before and during probiotic/placebo intake.
Main Results:
- Significantly higher colonization rates of Lactobacillus (93% vs 46%) and Bifidobacterium (100% vs 69%) in the probiotic group.
- Earlier colonization observed: 5 weeks for Lactobacillus and 1 week for Bifidobacterium.
- No significant impact on fecal immunological profile, but a decreasing trend in Th17 response noted.
Conclusions:
- The probiotic combination effectively enhanced earlier colonization of key beneficial bacteria in preterm infants.
- This probiotic supplementation represents a promising strategy for modulating the gut microbiota in vulnerable preterm populations.
Objective:
To evaluate the effect of a new probiotic strain combination, Ligilactobacillus salivarius subsp infantis PS11603 and Bifidobacterium longum PS10402, on gut bacterial colonization of preterm infants.
Methods:
A randomized, double-blind, placebo-controlled study was conducted in preterm infants from 28 weeks + 0days to 30 weeks + 6days of gestation. Thirty preterm infants were randomly selected after birth to receive either probiotics or placebo. Stool samples were collected before product intake and then sequentially during the first weeks of their admission. Classical microbiological, metagenomics and multiplex immunological analyses were performed to assess the bacterial and immune profile of the samples.
Results:
Twenty-seven infants completed the study (14 vs 13, probiotic and placebo groups). A higher number of participants were colonized by Lactobacilli in the probiotic group than in the placebo group (93% vs 46%; P = 0.013). Similar results were obtained when analysing bifidobacterial colonization (100% vs 69%; P = 0.041). Earlier colonization was observed in the probiotics group versus the placebo group, specifically 5 weeks for Lactobacillus and 1 week for Bifidobacterium. Although no effect was observed in the faecal immunological profile, a decreasing trend could be observed in Th17 response during the first week of probiotic treatment. None of the adverse events (AEs) registered were related to product intake.
Conclusion:
Probiotic supplementation with L salivarius PS11603 and B longum subsp. infantis PS10402 enhanced an earlier colonization of Lactobacillus and Bifidobacterium in preterm infants' guts in 5 and 1 week, respectively. A higher number of infants were colonized by Lactobacilli with the probiotics' intake at the end of the study.

