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口服硫酸软骨素和益生元治疗犬炎症性肠病:一项随机对照临床试验。

Oral chondroitin sulfate and prebiotics for the treatment of canine Inflammatory Bowel Disease: a randomized, controlled clinical trial.

作者信息

Segarra Sergi, Martínez-Subiela Silvia, Cerdà-Cuéllar Marta, Martínez-Puig Daniel, Muñoz-Prieto Alberto, Rodríguez-Franco Fernando, Rodríguez-Bertos Antonio, Allenspach Karin, Velasco Alfonso, Cerón José

机构信息

R&D Bioiberica SA, Pça. Francesc Macià 7, 08029, Barcelona, Spain.

Interlab-UMU, Campus de Excelencia "Mare Nostrum", University of Murcia, Campus Espinardo, 30071, Murcia, Spain.

出版信息

BMC Vet Res. 2016 Mar 10;12:49. doi: 10.1186/s12917-016-0676-x.

Abstract

BACKGROUND

Canine inflammatory bowel disease (IBD) is a chronic enteropathy of unknown etiology, although microbiome dysbiosis, genetic susceptibility, and dietary and/or environmental factors are hypothesized to be involved in its pathogenesis. Since some of the current therapies are associated with severe side effects, novel therapeutic modalities are needed. A new oral supplement for long-term management of canine IBD containing chondroitin sulfate (CS) and prebiotics (resistant starch, β-glucans and mannaoligosaccharides) was developed to target intestinal inflammation and oxidative stress, and restore normobiosis, without exhibiting any side effects. This double-blinded, randomized, placebo-controlled trial in dogs with IBD aims to evaluate the effects of 180 days administration of this supplement together with a hydrolyzed diet on clinical signs, intestinal histology, gut microbiota, and serum biomarkers of inflammation and oxidative stress.

RESULTS

Twenty-seven client-owned biopsy-confirmed IBD dogs were included in the study, switched to the same hydrolyzed diet and classified into one of two groups: supplement and placebo. Initially, there were no significant differences between groups (p > 0.05) for any of the studied parameters. Final data analysis (supplement: n = 9; placebo: n = 10) showed a significant decrease in canine IBD activity index (CIBDAI) score in both groups after treatment (p < 0.001). After treatment, a significant decrease (1.53-fold; p < 0.01) in histologic score was seen only in the supplement group. When groups were compared, the supplement group showed significantly higher serum cholesterol (p < 0.05) and paraoxonase-1 (PON1) levels after 60 days of treatment (p < 0.01), and the placebo group showed significantly reduced serum total antioxidant capacity (TAC) levels after 120 days (p < 0.05). No significant differences were found between groups at any time point for CIBDAI, WSAVA histologic score and fecal microbiota evaluated by PCR-restriction fragment length polymorphism (PCR-RFLP). No side effects were reported in any group.

CONCLUSIONS

The combined administration of the supplement with hydrolyzed diet over 180 days was safe and induced improvements in selected serum biomarkers, possibly suggesting a reduction in disease activity. This study was likely underpowered, therefore larger studies are warranted in order to demonstrate a supplemental effect to dietary treatment of this supplement on intestinal histology and CIBDAI.

摘要

背景

犬炎性肠病(IBD)是一种病因不明的慢性肠病,尽管微生物群落失调、遗传易感性以及饮食和/或环境因素被认为与发病机制有关。由于目前的一些治疗方法存在严重的副作用,因此需要新的治疗方式。一种用于犬IBD长期管理的新型口服补充剂被开发出来,其含有硫酸软骨素(CS)和益生元(抗性淀粉、β-葡聚糖和甘露寡糖),旨在针对肠道炎症和氧化应激,并恢复正常微生物群落,且不表现出任何副作用。这项针对患有IBD的犬的双盲、随机、安慰剂对照试验旨在评估这种补充剂与水解饮食联合使用180天对临床症状、肠道组织学、肠道微生物群以及炎症和氧化应激血清生物标志物的影响。

结果

27只客户拥有的经活检确诊为IBD的犬被纳入研究,改为相同的水解饮食,并分为两组之一:补充剂组和安慰剂组。最初,两组在任何研究参数上均无显著差异(p>0.05)。最终数据分析(补充剂组:n = 9;安慰剂组:n = 10)显示,两组治疗后犬IBD活动指数(CIBDAI)评分均显著降低(p<0.001)。治疗后,仅补充剂组的组织学评分显著降低(1.53倍;p<0.01)。比较两组时,补充剂组在治疗60天后血清胆固醇(p<0.05)和对氧磷酶-1(PON1)水平显著升高(p<0.01),安慰剂组在120天后血清总抗氧化能力(TAC)水平显著降低(p<0.05)。在任何时间点,通过聚合酶链反应-限制性片段长度多态性(PCR-RFLP)评估的CIBDAI、世界小动物兽医师协会(WSAVA)组织学评分和粪便微生物群在两组之间均未发现显著差异。任何组均未报告副作用。

结论

补充剂与水解饮食联合使用180天是安全的,并能使选定的血清生物标志物得到改善,这可能表明疾病活动度降低。本研究的样本量可能不足,因此需要进行更大规模的研究,以证明这种补充剂对饮食治疗在肠道组织学和CIBDAI方面的补充作用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6973/4785639/f3934bf0febd/12917_2016_676_Fig1_HTML.jpg

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