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Pre-clinical evaluation of the effect of co-medication with antibiotics and oral steroids in Göttingen Minipigs on the biological activity of the probiotic medicinal product TSO ( Trichuris suis ova)
Parasitology Research ( IF 2 ) Pub Date : 2021-01-06 , DOI: 10.1007/s00436-020-07004-8
M. V. Prosberg , H. Kringel , J. S. Kapel , B. S. Kapel , B. L. Fredensborg , A. M. Petersen , L. H. Hansen , D. S. Nielsen , H. S. Kapel , K. R. Jacobsen , L. F. Mikkelsen , C. M. O. Kapel

The probiotic medicinal product TSO (Trichuris suis ova) is administered to patients with active ulcerative colitis in an ongoing clinical phase IIb trial where the typical co-medications are steroids (prednisolone or budesonide) and antibiotics (e.g., phenoxymethylpenicillin). The present pre-clinical study evaluates the effects of these co-medications on the biological activity of TSO in Göttingen Minipigs. This translationally relevant pre-clinical model allows administration of TSO with and without oral steroids or antibiotics in a manner similar to the administration to patients, followed by quantification of the biological activity of TSO. The biological activity of TSO was not affected by oral steroids but was reduced by oral antibiotics. Fecal calprotectin, the common marker of intestinal inflammation in patients with UC, did not differ between groups.



中文翻译:

临床前评估哥廷根小型猪中抗生素和口服类固醇联合用药对益生菌药用产品TSO(Trichuris suis ova)生物学活性的影响

益生菌药物TSO(Trichuris suis在一项正在进行的临床IIb期临床试验中,对患有活动性溃疡性结肠炎的患者给予ova)治疗,其中典型的联合用药是类固醇(泼尼松龙或布地奈德)和抗生素(例如苯氧甲基青霉素)。目前的临床前研究评估了这些联合用药对哥廷根小型猪中TSO生物学活性的影响。这种与翻译相关的临床前模型允许以与向患者给药相似的方式在有或没有口服类固醇或抗生素的情况下给予TSO,然后对TSO的生物学活性进行定量。TSO的生物学活性不受口服类固醇的影响,但受口服抗生素的影响而降低。粪便钙卫蛋白是UC患者肠道炎症的常见标志物,两组之间无差异。

更新日期:2021-01-07
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