Investigating the Effect of Synbiotic Supplementation on Inflammatory Indices in Critically Ill Septic Children: a Triple Blind Randomized Controlled Trial.
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Sepsis is a major global health challenge associated with high mortality and long-term disabilities, with gut microbiota playing an important role in its pathophysiology. Probiotics and synbiotics may help restore microbial balance and modulate the inflammatory response. This study aimed to assess whether synbiotic supplementation could reduce inflammatory biomarkers and improve clinical outcomes in children with sepsis admitted to the pediatric intensive care unit compared with placebo. Fifty-four patients with sepsis were randomly assigned to receive either a synbiotic supplement (KidiLact) or a placebo. Participants consumed two sachets daily for 4-7 days. The study evaluated inflammatory markers, including interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR), as well as clinical outcomes and mortality. After the intervention, the synbiotic group had significantly lower CRP (p = 0.004), IL-6 (p < 0.001), and TNF-α (p < 0.001) levels than the placebo group. IL-6 and TNF-α decreased by 92.57% and 39.63%, respectively, in the synbiotic group, with statistically significant differences compared with placebo (IL-6: p < 0.001; TNF-α: p < 0.001). No statistically significant differences were observed between groups in clinical outcomes, including length of hospitalization, duration of PICU stay, duration of mechanical ventilation, duration of antibiotic therapy, or mortality. Daily administration of two sachets of the synbiotic supplement for 4-7 days may improve inflammatory biomarkers in children with sepsis admitted to the pediatric intensive care unit. However, no statistically significant differences in clinical outcomes or mortality were detected. Larger and adequately powered studies are needed to determine whether synbiotic supplementation improves clinical outcomes in this population. IRCT, IRCT20230523058266N1 Registered 30 October 2023, https://irct.behdasht.gov.ir/trial/71397 .