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丁酸钠对新诊断为炎症性肠病的儿童和青少年的疗效:随机安慰剂对照多中心试验。

Sodium Butyrate Effectiveness in Children and Adolescents with Newly Diagnosed Inflammatory Bowel Diseases-Randomized Placebo-Controlled Multicenter Trial.

机构信息

II Gastroenterology Department, Centre of Postgraduate Medical Education, 01-813 Warsaw, Poland.

Gastroenterology Department, Bielanski Hospital, Ceglowska 80 Str., 01-807 Warsaw, Poland.

出版信息

Nutrients. 2022 Aug 11;14(16):3283. doi: 10.3390/nu14163283.


DOI:10.3390/nu14163283
PMID:36014789
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9414716/
Abstract

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.

摘要

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。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3d3/9414716/124a679e89cd/nutrients-14-03283-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3d3/9414716/5f920fdc4e2f/nutrients-14-03283-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3d3/9414716/124a679e89cd/nutrients-14-03283-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3d3/9414716/5f920fdc4e2f/nutrients-14-03283-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3d3/9414716/124a679e89cd/nutrients-14-03283-g002.jpg

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[1]
Sodium Butyrate Effectiveness in Children and Adolescents with Newly Diagnosed Inflammatory Bowel Diseases-Randomized Placebo-Controlled Multicenter Trial.

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引用本文的文献

[1]
The role of probiotics, prebiotics, and synbiotics in the treatment of inflammatory bowel diseases: an overview of recent clinical trials.

Front Syst Biol. 2025-4-16

[2]
Linking Short-Chain Fatty Acids to Systemic Homeostasis: Mechanisms, Therapeutic Potential, and Future Directions.

J Nutr Metab. 2025-7-28

[3]
Clinical Efficacy of Sodium Butyrate in Managing Pediatric Inflammatory Bowel Disease.

Life (Basel). 2025-5-31

[4]
Synergistic gut microbiome-mediated degradation of polysaccharides and polysaccharides into butyric acid: a metatranscriptomic analysis.

Microbiol Spectr. 2025-7

[5]
Gut microbiota-derived short-chain fatty acids and their role in human health and disease.

Nat Rev Microbiol. 2025-5-13

[6]
Gut-directed therapeutics in inflammatory bowel disease.

Curr Opin Gastroenterol. 2025-7-1

[7]
Butyrate inhibits histone deacetylase 2 expression to alleviate liver fibrosis in biliary atresia.

BMC Pediatr. 2025-4-12

[8]
Sodium butyrate inhibits activation of ROS/NF-κB/NLRP3 signaling pathway and angiogenesis in human retinal microvascular endothelial cells.

Int Ophthalmol. 2025-3-18

[9]
Microbiota-derived metabolites in inflammatory bowel disease.

Semin Immunopathol. 2025-3-4

[10]
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Curr Microbiol. 2024-11-26

本文引用的文献

[1]
The Effects of High Fiber Rye, Compared to Refined Wheat, on Gut Microbiota Composition, Plasma Short Chain Fatty Acids, and Implications for Weight Loss and Metabolic Risk Factors (the RyeWeight Study).

Nutrients. 2022-4-17

[2]
Association between Fecal Short-Chain Fatty Acid Levels, Diet, and Body Mass Index in Patients with Inflammatory Bowel Disease.

Biology (Basel). 2022-1-10

[3]
Microbiota metabolite butyrate constrains neutrophil functions and ameliorates mucosal inflammation in inflammatory bowel disease.

Gut Microbes. 2021

[4]
Butyrate and the Intestinal Epithelium: Modulation of Proliferation and Inflammation in Homeostasis and Disease.

Cells. 2021-7-14

[5]
The Effect of Sodium Butyrate Enemas Compared with Placebo on Disease Activity, Endoscopic Scores, and Histological and Inflammatory Parameters in Inflammatory Bowel Diseases: A Systematic Review of Randomised Controlled Trials.

Complement Med Res. 2021

[6]
The Usefulness of Microencapsulated Sodium Butyrate Add-On Therapy in Maintaining Remission in Patients with Ulcerative Colitis: A Prospective Observational Study.

J Clin Med. 2020-12-4

[7]
Oral butyrate modulates the gut microbiota in patients with inflammatory bowel disease, most likely by reversing proinflammatory metabolic reprogramming of colonocytes.

Neurogastroenterol Motil. 2021-1

[8]
Sodium Butyrate Alleviates Mouse Colitis by Regulating Gut Microbiota Dysbiosis.

Animals (Basel). 2020-7-7

[9]
Determination of butyric acid dosage based on clinical and experimental studies - a literature review.

Prz Gastroenterol. 2020

[10]
Microbiota-derived butyrate regulates intestinal inflammation: Focus on inflammatory bowel disease.

Pharmacol Res. 2020-9

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