Pre-clinical evaluation of the effect of co-medication with antibiotics and oral steroids in Gottingen Minipigs on the biological activity of the probiotic medicinal product TSO (Trichuris suis ova)

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 Gottingen 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.

Automated summary

In an ongoing clinical trial on ulcerative colitis patients, the probiotic medicinal product TSO is being administered with steroids and antibiotics. A pre-clinical study on Gottingen Minipigs evaluated the effects of these medications on the biological activity of TSO, showing that oral steroids did not affect TSO but oral antibiotics did. Fecal calprotectin levels, a marker of intestinal inflammation, did not show significant differences among groups.