PRIMAL fecal samples shotgun metagenome sequencing

The PRiming IMmunity At the beginning of Life (PRIMAL) trial (German Clinical Trials Register: DRKS00013197) was a multicenter, double-blind, placebo-controlled, group sequential, phase 3 randomized clinical trial conducted from April 2018 to June 2020 across 18 German neonatal units. PRIMAL aimed to study the effects of probiotic interventions on colonization with multidrug-resistant organisms or highly epidemic bacteria (MDRO+) and early microbiome development in preterm infants born at gestational ages of 28 to 32 weeks. Specifically, the trial examined the efficacy of Bifidobacterium longum subsp. infantis, Bifidobacterium animalis subsp. lactis (BB-12), and Lactobacillus acidophilus (La-5) probiotics in preventing MDRO+ colonization and in shaping the microbiome of preterm infants toward the eubiotic state observed in healthy full-term infants. The intervention consisted of a 28-day course of multistrain probiotics diluted in human milk or formula, initiated within the first 72 hours of life.