Effect of probiotics on intestinal permeability in critically ill children with sepsis: preliminary results from a double-blind, placebo-controlled trial.

PURPOSE: The objective of this study was to evaluate whether probiotics have effects on intestinal permeability in children with sepsis.

METHODS

Septic children who were admitted to the pediatric intensive care unit (PICU) were included in this randomized double-blind study. Children received 2*109 CFU/day probiotics or placebo for 7 days. The primary outcome was change in the markers of intestinal permeability, the serum levels of zonulin and lipopolysaccharide-binding protein (LBP), within 7 days. The secondary outcomes included inflammatory cytokines such as interleukin (IL)-6, IL-10, and C-reactive protein (CRP), changes in sequential organ failure assessment (SOFA) score, need for mechanical ventilation and vasoactive, multiple organ dysfunction syndromes (MODS), septic shock, and healthcare-associated infections (HCAI)s, duration of PICU/hospital stays, and hospital mortality.

RESULTS

After 1 week of therapy, the levels of zonulin and LBP were reduced in the probiotic group compared to the placebo group, albeit there were no significant between-group differences for both (P = 0.88 for zonulin, P = 0.53 for LBP). In terms of inflammatory cytokines, probiotic usage led to a significant reduction in IL-6 (- 25.1 ± 29.1 pg/mL, P = 0.001) and an increase in IL-10 levels (25.4 ± 41.6 pg/mL, P < 0.001) with a significant difference between the two groups (P < 0.001). There were no differences between groups for other secondary outcomes, PICU/hospital stay, and mortality. Likewise, no serious side effects were seen after probiotic treatment in the study group.

CONCLUSION

Treatment of pediatric septic with probiotics was followed by improvement in inflammatory cytokines. Although we are not able to infer those probiotics provided benefit for intestinal permeability markers and known important clinical outcomes in pediatric sepsis.

TRIAL REGISTRY: Registered at the Iranian Registry of Clinical Trials ( www.irct.ir ) with the number IRCT20170202032367N10.