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Evidence-Based Supplement Research
Evidence-Based Supplement Research

Study Design

Type
Observational
Sample size
n = 41
Population
79 antibiotic-exposed preterm infants admitted to the neonatal intensive care unit (NICU) between February 2020 and April 2022
Methods
prospective observational study; infants divided into two groups based on clinical LCBE administration: probiotic group (n = 41) and non-probiotic group (n = 38); gut microbiota analyzed via 16S rRNA gene sequencing of 274 fecal samples

Background

Early antibiotic exposure frequently induces gut dysbiosis in preterm infants. Although probiotics, such as the live combined preparation of Bacillus subtilis and Enterococcus faecium (LCBE), may mitigate this disruption, high-quality clinical evidence in this high-risk population remains limited. This prospective observational study investigated the association of early LCBE supplementation with the incidence of feeding intolerance (FI) and gut microbiota composition in antibiotic-exposed preterm infants.

Methods

Seventy-nine antibiotic-exposed preterm infants admitted to the neonatal intensive care unit (NICU) between February 2020 and April 2022 were enrolled and divided into two groups based on clinical LCBE administration: the probiotic group (n = 41) and the non-probiotic group (n = 38). Clinical data were collected prospectively. Gut microbiota composition was analyzed via 16S rRNA gene sequencing of 274 fecal samples (144 from the probiotic group, 130 from the non-probiotic group).

Results

LCBE supplementation was associated with a significantly lower incidence of FI (17.07% vs. 44.74%; adjusted OR = 0.156, 95% CI: 0.050-0.491, p = 0.001). Notably, this protective association became evident only during the post-supplementation period (postnatal days 21-28), suggesting a delayed but sustained effect. The intervention was well-tolerated, with no treatment-related adverse events reported. In infants receiving LCBE, we observed suppression of potentially pathogenic bacteria, including Enterococcus and Klebsiella, alongside the preservation of beneficial genera such as Bifidobacterium and Lactobacillus. These microbial shifts were accompanied by a more stable and mature gut microbiota profile.

Conclusions

In antibiotic-exposed preterm infants, early LCBE supplementation was associated with a significant reduction in the incidence of feeding intolerance. This clinical benefit was accompanied by favorable gut microbiota modulation, characterized by the suppression of opportunistic pathogen overgrowth and the preservation of beneficial commensal taxa. These findings support the potential role of LCBE as a safe and well-tolerated adjunctive intervention in this vulnerable population, offering practical insights for neonatologists.

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