Probiotics and preemies: Ensuring safety amid uncertainty

As a neonatologist dedicated to the care of premature infants, I constantly navigate the delicate balance between innovation and caution in the treatments we offer. Probiotics, widely praised for their potential to reduce the incidence of necrotizing enterocolitis (NEC), have emerged as a promising intervention in NICUs. However, the lack of FDA regulation for these products raises critical questions about their safety, efficacy and ethical use in our most vulnerable patients.

NEC is a severe and potentially life-threatening condition that primarily affects premature infants. It involves the inflammation and, in some cases, the death of intestinal tissue, leading to a cascade of complications that can result in prolonged hospitalization, surgery or even death. Despite advances in neonatal care, NEC remains a leading cause of morbidity and mortality in preterm infants, making the search for effective preventive measures, like probiotics, more urgent.

In the NICU, every decision we make has profound implications. The idea that we can potentially prevent a devastating condition like NEC with something as simple as probiotics is both exciting and daunting. Yet, the current landscape of probiotic use in U.S. NICUs is anything but uniform.

With colleagues, I recently conducted a survey and found that a growing number of hospitals have integrated probiotics into their standard care protocols for very low birth weight infants, while others, approach with caution, weighing the benefits against the uncertainties.

One of the main reasons for variability in probiotic use is the absence of FDA oversight. Probiotics are classified as dietary supplements, meaning they do not undergo the rigorous testing and approval processes that pharmaceutical drugs do. This lack of regulation leads to significant differences in the quality and composition of probiotic products, creating a gray area where the safety of our patients could be compromised.

As a physician, I am deeply concerned about the implications of this regulatory gap. When I recommend a treatment, I want to be confident in its consistency and safety. With probiotics, that confidence is hard to come by. Without standardized product quality, we risk exposing our fragile patients to potentially harmful or ineffective strains.

Ethically, this presents a dilemma. How can I ensure that parents are making fully informed decisions about their infant’s care when there is so much uncertainty? It is my responsibility to explain that probiotics, despite their potential benefits, are not regulated like other medications we use in the NICU. Parents need to understand that these products have not been subjected to the same rigorous testing for safety and efficacy, which is a conversation I must navigate carefully and transparently.

To truly harness the benefits of probiotics while safeguarding our patients, I believe there is an urgent need for better regulation and the establishment of consensus guidelines. The FDA could consider creating a specific regulatory category for probiotics used in clinical settings, ensuring that only high-quality, evidence-based products make it to our NICUs. Additionally, professional organizations such as the American Academy of Pediatrics could help develop standardized guidelines based on the latest research, providing us with a clearer framework for their use.

As we continue to explore the potential of probiotics in preventing NEC, it is imperative that we, as a medical community, advocate for these changes. The health and safety of our premature infants depend on it. Ensuring that our practices are both evidence-based and ethically sound is not just our duty – it is the cornerstone of neonatal care.

By Dr. Morcos Hanna, assistant professor of pediatrics – neonatology at Baylor College of Medicine