Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
Department of Pediatrics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
Trials. 2024 Oct 24;25(1):712. doi: 10.1186/s13063-024-08514-x.
Sepsis, a severe inflammatory response to infection, is a global health priority due to its high mortality and long-term disability rates. Its pathophysiology involves both inflammation and immune suppression. Managing sepsis requires significant healthcare resources and expenditure, with sepsis being a leading cause of hospital costs. Gut microbiotas play a crucial role in sepsis, and probiotics show promise in managing it by restoring microbial balance. Despite advances, targeted therapies for sepsis remain elusive, necessitating innovative approaches such as probiotic therapy.
Fifty-four eligible patients with sepsis will be randomly assigned to either the synbiotic or placebo group. The synbiotic supplement, KidiLact, comprises ten probiotic strains and prebiotic fructooligosaccharides. Participants will receive two sachets daily for 7 days, mixed with sterile water and administered orally or via gavage. Inflammatory factors including interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-α), C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR) will be evaluated. Anthropometric measurements, nutritional assessment, biochemical analysis, and clinical evaluation will be conducted to assess treatment outcomes. Statistical analysis will be performed to compare results between the two groups, employing SPSS version 19 with a significance level of P < .05.
This randomized clinical trial aims to evaluate synbiotic supplementation effects on inflammatory markers and clinical outcomes in pediatric sepsis patients in the pediatric intensive care unit (PICU). Probiotics have shown promise in reducing proinflammatory cytokines like IL-6, TNF-α, and CRP, which are vital in the inflammatory response. Synbiotics can enhance gut integrity, preventing pathogen translocation and reducing inflammation. If our expectations regarding the effects of probiotics are correct, we can use them as a cost-effective supplement to improve the condition of pediatric sepsis in hospitals.
IRCT,IRCT20230523058266N1 Registered 30 October 2023, https://irct.behdasht.gov.ir/trial/71397 .
脓毒症是一种严重的感染性炎症反应，其高死亡率和长期残疾率使其成为全球卫生重点。其病理生理学涉及炎症和免疫抑制。脓毒症的管理需要大量的医疗资源和支出，是医院费用的主要原因。肠道微生物群在脓毒症中起着至关重要的作用，益生菌通过恢复微生物平衡在管理脓毒症方面显示出前景。尽管取得了进展，但针对脓毒症的靶向治疗仍然难以捉摸，需要采用益生菌治疗等创新方法。
将 54 名符合条件的脓毒症患者随机分配到合生元组或安慰剂组。合生元补充剂 KidiLact 包含十种益生菌株和益生元低聚果糖。参与者将每天服用两袋，用无菌水混合，口服或管饲，持续 7 天。将评估包括白细胞介素-6（IL-6）、肿瘤坏死因子-α（TNF-α）、C 反应蛋白（CRP）和红细胞沉降率（ESR）在内的炎症因子。将进行人体测量、营养评估、生化分析和临床评估，以评估治疗结果。将使用 SPSS 版本 19 进行统计分析，比较两组之间的结果，显著性水平为 P < .05。
本随机临床试验旨在评估合生元补充剂对儿科重症监护病房（PICU）中儿童脓毒症患者炎症标志物和临床结局的影响。益生菌已显示出减少白细胞介素-6、肿瘤坏死因子-α和 CRP 等促炎细胞因子的潜力，这些细胞因子在炎症反应中至关重要。合生元可以增强肠道完整性，防止病原体易位并减少炎症。如果我们对益生菌效果的预期是正确的，我们可以将其作为一种具有成本效益的补充剂，改善医院中儿童脓毒症的病情。
IRCT，IRCT20230523058266N1 于 2023 年 10 月 30 日注册，https://irct.behdasht.gov.ir/trial/71397。
