SEPSIS Lactobacillus plantarum ATCC 202195 Microbiome Study

Recent randomized controlled trials (RCTs) have demonstrated the beneficial effects of probiotics and/or prebiotics, compared to placebo, for preventing infections in preterm and/or LBW infant. Some of the most compelling evidence comes from a recent randomized, double blind, placebo-controlled trial conducted by Panigrahi and colleagues, where newborns (= 35 weeks 'gestation and = 2,000 grams) residing in rural India were randomized to receive Lactobacillus plantarum (L. plantarum) ATCC 202195 plus fructooligosaccharide (FOS), or placebo, once daily for seven consecutive days, starting on day two to four of life. Relative to the placebo group, infants in the synbiotic group had a 40% lower risk of the combined primary outcome of sepsis and all-cause mortality, and a 78% lower risk of culture-confirmed sepsis. As a result of the promising safety profile and strong mechanistic rationale regarding its plausible probiotic effects, L. plantarum has garnered interest as a potential intervention for preventing sepsis and pSBI in infants. Although the Panigrahi et al. study provides strong evidence for the proposed beneficial effects,the effects of L. plantarum administration on the infant microbiome has not been fully described. Most of what we know about the microbiome comes from high-income settings. This is because, low- and middle-income countries (LMICs) are currently underrepresented in global microbiome study. In addition, recent work highlights the influence of geography on the composition and stability of the gut microbiota. This study will examine the effects of neonatal oral administration of Lactobacillus plantarum (L. plantarum) ATCC 202195 (109 CFU/day) with fructooligosaccharide (FOS), versus placebo, on the community structure, diversity and metabolite production of the microbiota of infants in Dhaka, Bangladesh