II Gastroenterology Department, Centre of Postgraduate Medical Education, 01-813 Warsaw, Poland.
Gastroenterology Department, Bielanski Hospital, Ceglowska 80 Str., 01-807 Warsaw, Poland.
Nutrients. 2022 Aug 11;14(16):3283. doi: 10.3390/nu14163283.
BACKGROUND: Butyric acid's effectiveness has not yet been assessed in the pediatric inflammatory bowel disease (IBD) population. This study aimed to evaluate the effectiveness of oral sodium butyrate as an add-on to standard therapy in children and adolescents with newly diagnosed IBD. METHODS: This was a prospective, randomized, placebo-controlled multicenter study. Patients aged 6-18 years with colonic Crohn's disease or ulcerative colitis, who received standard therapy depending on the disease's severity, were randomized to receive 150 mg sodium butyrate twice a day (group A) or placebo (group B). The primary outcome was the difference in disease activity and fecal calprotectin concentration between the two study groups measured at 12 weeks of the study. RESULTS: In total, 72 patients with initially active disease completed the study, 29 patients in group A and 43 in group B. At week 12 of the study, the majority of patients achieved remission. No difference in remission rate or median disease activity was found between the two groups ( = 0.37 and 0.31, respectively). None of the patients reported adverse events. CONCLUSIONS: A 12-week supplementation with sodium butyrate, as adjunctive therapy, did not show efficacy in newly diagnosed children and adolescents with IBD.
背景:丁酸在儿科炎症性肠病(IBD)患者中的疗效尚未得到评估。本研究旨在评估口服丁酸钠作为辅助标准治疗在新诊断为 IBD 的儿童和青少年中的疗效。
方法:这是一项前瞻性、随机、安慰剂对照的多中心研究。年龄在 6-18 岁的患有结肠克罗恩病或溃疡性结肠炎的患者,根据疾病的严重程度接受标准治疗,随机分为每天两次接受 150 毫克丁酸钠(A 组)或安慰剂(B 组)。主要结局是在研究的 12 周时,两组之间疾病活动度和粪便钙卫蛋白浓度的差异。
结果:共有 72 名最初患有活动性疾病的患者完成了研究,A 组 29 名,B 组 43 名。在研究的第 12 周,大多数患者达到缓解。两组之间缓解率或中位数疾病活动度无差异(分别为 0.37 和 0.31)。没有患者报告不良反应。
结论:在新诊断为 IBD 的儿童和青少年中,补充丁酸钠作为辅助治疗,12 周的治疗并没有显示出疗效。
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