IPA Executive Director reacts to study on probiotic use in preterm infants

A recent retrospective cohort study published in Pediatrics has reinforced the potential benefits of probiotics in lowering mortality rates among preterm infants.

It underscored the importance of probiotics in neonatal care, particularly in reducing necrotizing enterocolitis (NEC) among preterm infants, IPA’s Paraskevakos told NutraIngredients. However, he acknowledged that the absence of a clear regulatory framework for administering probiotics in this vulnerable population poses an ongoing challenge.

“Enough doctors, not just in Canada, clearly believe in probiotics for preterm infants and continue to use them to save lives at their own risk even amid the lack of a clear regulatory path for the use of a food/dietary supplement in a diseased population,” Paraskevakos said.

Due to the absence of “a formal non-drug route for administering probiotic products to preterm infants, these difficult decisions remain at the discretion of the parents supported by the careful evaluation of the attending medical team,” he added, urging regulators to prioritize the establishment of a structured pathway for probiotic use in neonatal care.

“It should be a major priority of the regulators to create and facilitate such a pathway as this is an urgent need for preterm babies who desperately need supplementation to promote colonization of the gastrointestinal tract in a controlled way.”

Industry implications: Strengthening the case for probiotic supplementation

Paraskevakos highlighted that the study aligned with existing industry perspectives on the efficacy of probiotics in neonatal care, reinforcing “what many in the industry, medical and scientific community already support: Probiotics play a crucial role in reducing mortality in preterm infants and strengthening “the case for probiotic supplementation as a standard of care in neonatal units.”

The study determined that among 32,667 eligible infants born before 34 weeks gestation, probiotics were associated with decreased mortality rates but had limited effects on NEC. The study also reported that probiotic sepsis was rare, occurring in 27 infants (1.4/1000) born before 34 weeks gestation.

While the study found limited effects on NEC and late-onset sepsis, Paraskevakos noted that these results were consistent with trends seen in other global cohorts: “The ability of probiotics to support overall survival remains a compelling reason for their inclusion in neonatal care strategies.”

For supplement manufacturers, he maintained there is an opportunity to invest in precision probiotic formulations tailored for preterm infants.

“Manufacturers investing in precision probiotic formulations tailored for preterm infants can help push the industry and patient care forward,” he said.

He added that industry stakeholders “can leverage these findings to foster trust with healthcare professionals, support education initiatives and drive innovation in infant probiotic supplementation,” though he acknowledged that regulatory uncertainty may hinder rapid market expansion.

He also emphasized the potential for maternal probiotic supplementation, as the study “opens doors for innovation in maternal probiotic supplements, ensuring beneficial microbial transfer from pregnancy through breastfeeding.”

Strain-specific research: A key to optimizing neonatal probiotics

One of the study’s limitations was its lack of strain-specific data, which Paraskevakos believed is critical to understanding the safety and effectiveness of probiotics, especially in vulnerable populations like preterm infants.

He noted, “Not all probiotics are the same: Different strains have distinct functions, and their effects cannot be generalized across species or even within the same genus, without proper clinical information.”

Further, he emphasized the need for research to identify optimal strains for neonatal care, suggesting that future studies could focus on strain selection and long-term outcomes to maximize benefits like gut microbiome support, reduced necrotizing enterocolitis risk and improved immune development.

Ensuring quality and safety in probiotic manufacturing

Paraskevakos also addressed the rare occurrence of probiotic-associated sepsis reported in the study and highlighted key industry considerations for ensuring probiotic safety in medically fragile populations.

“A probiotic product and a probiotic strain must be differentiated between each other,” he explained.

“A commercial probiotic product is comprised of the combination of a strain(s) of choice plus the necessary ingredients to achieve the delivery of a high quality, safe and efficacious product, therefore ALL ingredients in the product must be considered when manufacturing for these vulnerable populations, both active and non-active ingredients.”

Paraskevakos also outlined key factors that manufacturers must prioritize to ensure probiotic safety and efficacy, which included:

• Rigorous strain selection: utilizing well-documented strains with proven safety in preterm infants.
• Quality manufacturing: ensuring strict microbial purity and absence of contaminants.
• Validated quality control: following standardized protocols for potency, purity and identity testing.
• Transparent labeling and traceability: providing clear strain identification, CFU counts and transparent sourcing.

Communicating benefits and risks to healthcare providers and consumers

With growing interest in probiotics for neonatal care, Paraskevakos stressed the importance of clear and evidence-based communication with healthcare professionals and consumers.

While “probiotic use in this population of hospitalized preterm infants has been included in many hospital protocols globally,” he said, there is a need for rigorous safety measures and proper strain identification.

“Safety is always a top priority, [and] using well-researched probiotic strains with proven benefits in neonatal care is key. Healthcare professionals need clear, evidence-based guidance to make informed decisions.”

Future outlook

As probiotic research continues to expand, Paraskevakos remained optimistic about its potential impact on neonatal care. However, he urged continued collaboration between industry, regulators and healthcare professionals to ensure the safe and effective use of probiotics in preterm infants.

“Ongoing studies and collaboration between industry, regulators and healthcare experts will help ensure probiotics are used safely and effectively in neonatal care,” he said.

Source: Pediatrics 2025 155 (3). doi: 10.1542/peds.2024-069102. “Effectiveness and Risks of Probiotics in Preterm Infants”. Authors: Belal N. Alshaikh, MD, MSCE et al.