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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)

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Abstract

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.

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Data availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

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Funding

This work was supported by Ellegaard Göttingen Minipigs A/S that provided the minipigs and by ParaTech A/S that provided the TSO.

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Authors

Contributions

All authors have made substantial contributions to conception and design of the study and to revising the article for intellectual content and to final approval of the version to be submitted.

Prosberg MV, Kapel JS, Kapel BS, Kringel H. and Kapel CMO have contributed to acquisition, analysis, and interpretation of data and to drafting the article.

Corresponding author

Correspondence to H. Kringel.

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Conflicts of interests

Prosberg MV, Fredensborg BL, Petersen AM, Nielsen DS, and Hansen LH have no conflict of interest to declare that are relevant to the content of this article. Kringel H, Kapel JS, and Kapel, BS receive a salary from ParaTech A/S. Kapel CMO and Kapel HS declare financial relationship with ParaTech A/S. Mikkelsen LF and Jacobsen KR declare financial relationship with Ellegaard Göttingen Minipigs A/S.

Ethics approval

Animals were housed, and the study approved under Danish experimental license 2019-15-0201-00010, and the study followed current European and national regulations of animal welfare standards.

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Section Editor: Hiroshi Sato

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Prosberg, M.V., Kringel, H., Kapel, J.S. et al. 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). Parasitol Res 120, 743–746 (2021). https://doi.org/10.1007/s00436-020-07004-8

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  • DOI: https://doi.org/10.1007/s00436-020-07004-8

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