Department of Gastroenterology, Copenhagen University Hospital Hvidovre, Kettegaard Allé 30, 2650, Hvidovre, Denmark.
ParaTech A/S, Dr. Neergaards Vej 3, 2970, Hoersholm, Denmark.
Parasitol Res. 2021 Feb;120(2):743-746. doi: 10.1007/s00436-020-07004-8. Epub 2021 Jan 6.
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.
正在进行的临床试验 IIb 期将益生菌药物 TSO（猪鞭虫卵）用于治疗活动期溃疡性结肠炎患者，这些患者通常同时接受皮质类固醇（泼尼松龙或布地奈德）和抗生素（如苯氧甲基青霉素）治疗。本临床前研究评估了这些合并药物对豚鼠 TSO 生物学活性的影响。这种转化相关的临床前模型允许以类似于患者给药的方式给予 TSO 加用或不加用口服皮质类固醇或抗生素，然后定量 TSO 的生物学活性。口服皮质类固醇对 TSO 的生物学活性没有影响，但口服抗生素会降低 TSO 的生物学活性。粪便钙卫蛋白是 UC 患者肠道炎症的常用标志物，各组之间无差异。
