Prophylaxis of acute respiratory infections via improving the immune system in late preterm newborns with E. coli strain Nissle 1917: a controlled pilot trial Original paper

What was studied?

This pilot trial assessed the efficacy and safety of Escherichia coli Nissle 1917 (EcN) in improving immune competence and preventing acute respiratory infections (ARIs) in late preterm newborns. ARIs are common in this vulnerable population due to their underdeveloped immune systems. The study aimed to determine whether EcN, with its immunomodulatory properties, could reduce the incidence of these infections in the first month of life. The trial consisted of a 4-week treatment phase with EcN, followed by a 12-month follow-up phase.

Who was studied?

The study involved 62 late preterm newborns, aged 12-24 hours at enrollment, with a gestational age of 35-36 weeks. These newborns were born at a maternity hospital in Odessa, Ukraine, and were randomized into two groups: one receiving EcN (the treatment group) and the other receiving no treatment (the control group). The primary focus was on the incidence of ARIs during the first 28 days of life, and secondary outcomes included the number of ARI events and hospitalizations due to ARIs during the first year of life.

Most important findings

The primary outcome showed that the incidence of at least one ARI in the first 28 days of life was significantly lower in the EcN group (10%) compared to the control group (43.7%). This represented a 77% reduction in risk for ARIs in the EcN-treated newborns. Secondary analysis revealed a decrease in the average number of ARIs, the number of hospitalizations, and the duration of these hospitalizations in the EcN group compared to controls. Although this study was exploratory, the findings suggest that EcN may offer substantial protection against early-life infections in preterm newborns, with no adverse events recorded in the EcN group during the newborn phase.

Key implications

The study provides promising evidence that Escherichia coli Nissle 1917 can improve immune function in late preterm newborns, reducing the incidence of ARIs, which are a significant cause of morbidity in this population. These findings suggest that early administration of probiotics could be a valuable intervention for preventing infections in vulnerable preterm infants. Given that EcN was well tolerated and associated with a lower incidence of ARIs, it offers a potential strategy for reducing hospitalizations and improving overall health outcomes in preterm newborns. However, further large-scale randomized controlled trials are needed to confirm these benefits and explore long-term effects.