In the multi-centre, double-blind, placebo-controlled trial in nine neonatal intensive care units in four major cities in Colombia, infants born prematurely, with a birth weight of 2000 grams or smaller, were recruited. During the first 48 hours of life they were randomised to supplementation by either 10^8 CFU daily of Lactobacillus reuteri DSM 17938 (L. reuteri Protectis, n=372) or a corresponding placebo (n=378). Supplementation continued until death or discharge from the neonatal intensive care unit.
The results showed no significant differences between the group supplemented by Lactobacillus reuteri Protectis and placebo in the primary outcome death or nosocomial infections (p=0.38). NEC decreased by 40% in the Lactobacillus reuteri Protectis group compared to placebo (p=0.23).
Incidence of nosocomial pneumonia was reduced to 2.4% among the infants supplemented byLactobacillus reuteri Protectis compared to 5.0% of those in the placebo group, a reduction of 48% and almost reaching significance (p=0.06).
Significant effects in infants below 1500 grams
In the sub-group of highest risk infants, those with a birth weight below 1500 grams, Lactobacillus reuteri Protectis significantly decreased the number of feeding intolerance episodes, to 9.6% compared to 16.8% in the placebo group, a reduction of 43% (p=0.04). This probably explained the significantly reduced duration of hospitalisation in this group compared to placebo, 32.5 days versus 37 days respectively (p=0.03).
Largest probiotic study in premature infants
A total of 750 infants were included in the study, which was considerably less than the number planned (1110) and required to reach significance in the outcome parameters. The study was terminated early, which was related to substantial drops in recruitment rate and funding restrictions from the independent funding institute.
The safety of Lactobacillus reuteri Protectis in this high-risk population was confirmed and no nosocomial infections secondary to giving Lactobacillus reuteri Protectis were identified.