Objective: The aim of this study was to compare the efficacy of orally administered Lactobacillus reuteri (L. reuteri) versus nystatin in prevention of fungal colonization and invasive candidiasis in very low birth weight infants.
Methods: A prospective, randomized comparative study was conducted in preterm infants with a gestational age of ≤32 weeks and birth weight of ≤1500 g. Patients were randomized into two groups, to receive L. reuteri or nystatin. Skin and stool cultures were performed once a week for colonization and blood cultures for invasive infections. The trial was registered to ClinicalTrials.gov under identifier NCT01531192.
Results: A total of 300 preterm infants were enrolled (n = 150, for each group). Gastrointestinal colonization and skin colonization rates were not significantly different between the groups (18.7% versus 16%, p = 0.54 and 14% versus 12%, p = 0.6, respectively). Invasive candidiasis was detected in two patients of the probiotic group and one patient of the antifungal group. Proven sepsis, feeding intolerance, and duration of hospitalization were significantly lower in the probiotics group than in the antifungal group.
Conclusions: Prophylactic L. reuteri supplementation is as effective as nystatin, and more effective in reducing the incidence of proven sepsis in addition to its favorable effect on feeding intolerance.
Keywords: Candidal colonization; Lactobacillus reuteri; invasive candidiasis; nystatin; preterm infants.