Objective: We aim to assess the feasibility of a pragmatic randomized trial of antibiotics vs. no antibiotics in symptomatic premature infants after birth. Most premature infants are exposed to antibiotics after birth without evidence of benefit or harm for this practice. No study to date has attempted to randomize premature infants to antibiotics vs no antibiotics after birth. Study Design: Infants <33 weeks gestation admitted to the University of Florida Neonatal Intensive Care Unit were assigned to one of three groups after birth: (A) high risk, antibiotics indicated (B) low risk, antibiotics not indicated (C) eligible for un-blinded randomization (no antibiotics vs antibiotics). The primary outcome is a composite of serious adverse events including (necrotizing enterocolitis, late onset sepsis, bronchopulmonary dysplasia, and death). Odds ratios (and 95% CIs) were calculated to compare adverse event rates between the two randomized groups. Results. 186 subjects were enrolled (98 infants and 88 mothers) were enrolled over a 2-year period. 56% of infants (n=55) were randomized; 48% of infants randomized to the no antibiotics arm were switched and received antibiotics within the first 48 hours after birth. Serious adverse events were not significantly different between the randomization arms. Conclusion. This is the first prospective randomized trial of antibiotics vs no antibiotics after birth in symptomatic premature infants. The results of this trial establish a framework of feasibility for a larger multicentered trial that is needed to evaluate the risks and benefits of routine antibiotic exposure in premature infants.
The earliest predictors of future autoimmune diseases are a series of autoantibodies that are rarely evaluated and very within and between diseases. In addition, autoantibodies often appear just prior to disease onset. All of these factors make it difficult to apply interventions that might prevent disease. Earlier predictors of disease are needed. Here, a general population cohort was used to assess whether gut bacterial biomarkers could be identified prior to disease. Gut microbiome analysis on 1,741 one-year old Swedish children was performed on samples collected in the late 1990s. These children were then followed for 18 years for the incidence of five autoimmune diseases and autism. Specific bacterial strains in the gut microbiome of one-year-old children have been identified as exclusive to the 96 subjects (cases) who acquired type 1 diabetes, celiac disease, hypothyroidism, Crohns disease, juvenile idiopathic arthritis, or autism over their next 18 years. None of these strains were found in the 1,645 children (controls) who did not acquire any of these diseases. Ten other strains were exclusive to those who remained disease-free. In most cases, the presence or absence of these bacteria were strongly associated with: 1) high-risk class II human leukocyte antigen (HLA) alleles; 2) dietary factors; or 3) a combination of HLA genetics and diet. These results have three significant implications: 1) certain class II HLA haplotypes may serve as bacterial gatekeepers early in life, altering microbiome composition thereby creating the potential for dysbiosis and inflammation; 2) the gut microbiome dysbiosis and inflammation during infancy, largely derived from host HLA genetics and diet, may be a common precedent to all five autoimmune diseases and autism; and 3) HLA gatekeeping may prevent gut colonization of beneficial bacteria in those genetically at-risk individuals who could most benefit from probiotic therapy.
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