Multistrain probiotic tied to reduced risk of severe GI disease in preterm newborns
Chris Dall, MA59 minutes ago.
Antimicrobial Stewardship
Routine administration of a multistrain probiotic may help reduce the risk of a severe gastrointestinal disease in preterm infants, Dutch researchers reported yesterday in JAMA Network Open.
In an observational study conducted at two neonatal intensive care units (NICUs) in the Netherlands, researchers from Erasmus Medical Center and Amsterdam University Medical Center compared preterm infants before and after administration of a formula containing three strains of probiotic—Bifidobacterium infantis Bb-02, Bifidobacterium lactis BB-12, and Streptococcus thermophilus TH-4. They were evaluating whether the probiotic formula, administered via a gastric feeding tube, might reduce incidence of necrotizing enterecolitis (NEC), which is a major cause of illness and death in preterm infants.
NEC occurs when there’s a microbial imbalance and loss of beneficial bacteria in the gut, resulting in the overgrowth of potentially pathogenic bacteria and intestinal inflammation. “Probiotics may help prevent NEC by restoring microbial balance and suppressing pathogenic organisms,” the study authors wrote.
While the multistrain formula used in the study has been endorsed by the European Society for Paediatric Gastroenterology Hepatology and Nutrition and is widely used in Europe, there are safety concerns about using it in preterm infants, including rare cases of probiotic-associated sepsis. Group like the American Academy of Pediatrics have cautioned against routine administration in babies weighing less than 2.2 pounds.
“Recent regulatory warnings, including from the US Food and Drug Administration, have further emphasized the need for robust clinical data on both the benefits and risks of probiotics for this population,” the study authors wrote.
51% reduced risk of NEC
A total of 1,413 infants born from January 1, 2018, to July 1, 2024, were included in the study, with 598 in the preimplementation group and 815in the postimplementation group. Routine administration of the formula began in October 2020 in one of the NICUs and March 2021 in the other. Baseline characteristics, including gestational age (GA; 27.7 vs 27.9 weeks) and birthweight (BW; 2.09 vs 2.15 pounds), were similar in both groups.NEC incidence among the infants declined from 11.9% to 5.3% after implementation. After adjustments were made for potential confounders (including GA, sex, BW z -score, and prenatal corticosteroid use), probiotic administration was associated with a 51% lower risk of NEC (adjusted risk ratio [ARR], 0.49).
But all-cause mortality was similar before and after probiotic implementation (11.7% vs 11.5%; ARR, 1.06), and mortality among extremely preterm infants was also unchanged (ARR, 1.02). In addition, non–NEC-associated mortality was higher in infants who received probiotics (7.2% vs 9.6%; ARR, 1.42).
One case of probiotic sepsis occurred.
The researchers note the findings align with the results of a previous randomized clinical trial, which found that the same probiotic formulation was associated with a 54% lower NEC risk among infants with a GA of less than 32 weeks and weighing less than 3.31 pounds. “The comparable magnitude of association supports the formulation’s effectiveness in clinical practice,” they wrote.
“However, the observed increase in non–NEC-associated mortality warrants cautious interpretation and further investigation,” they concluded. “Future research should aim to harmonize probiotic formulations, clarify strain-specific effects, and identify subpopulations most likely to benefit.”