Randomized Clinical Trial Demonstrate the Safety Assessment of Dietzia natronolimnaea C79793-74 for Use as a Probiotic in Humans

Gissel García Menéndez; Josanne Soto; Jesus Barreto; Ángela Gutiérez; Carmen Soto; Ana Beatriz Pérez; Yudith Peña; Raul de Jesus Cano

doi:10.20944/preprints202311.1226.v1

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preprints.org > medicine and pharmacology > complementary and alternative medicine > doi: 10.20944/preprints202311.1226.v1

Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Randomized Clinical Trial Demonstrate the Safety Assessment of Dietzia natronolimnaea C79793-74 for Use as a Probiotic in Humans

Gissel García Menéndez

^* ,

Version 1 : Received: 18 November 2023 / Approved: 20 November 2023 / Online: 20 November 2023 (07:48:29 CET)

How to cite: García Menéndez, G.; Soto, J.; Barreto, J.; Gutiérez, Á.; Soto, C.; Beatriz Pérez, A.; Peña, Y.; Cano, R.D.J. Randomized Clinical Trial Demonstrate the Safety Assessment of Dietzia natronolimnaea C79793-74 for Use as a Probiotic in Humans. Preprints 2023, 2023111226. https://doi.org/10.20944/preprints202311.1226.v1 García Menéndez, G.; Soto, J.; Barreto, J.; Gutiérez, Á.; Soto, C.; Beatriz Pérez, A.; Peña, Y.; Cano, R.D.J. Randomized Clinical Trial Demonstrate the Safety Assessment of Dietzia natronolimnaea C79793-74 for Use as a Probiotic in Humans. Preprints 2023, 2023111226. https://doi.org/10.20944/preprints202311.1226.v1

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MDPI and ACS Style

García Menéndez, G.; Soto, J.; Barreto, J.; Gutiérez, Á.; Soto, C.; Beatriz Pérez, A.; Peña, Y.; Cano, R.D.J. Randomized Clinical Trial Demonstrate the Safety Assessment of Dietzia natronolimnaea C79793-74 for Use as a Probiotic in Humans. Preprints 2023, 2023111226. https://doi.org/10.20944/preprints202311.1226.v1

APA Style

García Menéndez, G., Soto, J., Barreto, J., Gutiérez, Á., Soto, C., Beatriz Pérez, A., Peña, Y., & Cano, R.D.J. (2023). Randomized Clinical Trial Demonstrate the Safety Assessment of <em>Dietzia natronolimnaea</em> C79793-74 for Use as a Probiotic in Humans. Preprints. https://doi.org/10.20944/preprints202311.1226.v1

Chicago/Turabian Style

García Menéndez, G., Yudith Peña and Raul de Jesus Cano. 2023 "Randomized Clinical Trial Demonstrate the Safety Assessment of <em>Dietzia natronolimnaea</em> C79793-74 for Use as a Probiotic in Humans" Preprints. https://doi.org/10.20944/preprints202311.1226.v1

Abstract

Dietzia natronolimnaea C79793-74 has emerged as a potential probiotic strain with implications for managing Crohn's disease. This study evaluates the safety profile of D. natronolimnaea C79793-74 as a probiotic sup-plement. Genotypic characterization involved a 16S rRNA gene and genomic sequencing and genome an-notation. The safety assessment included interrogation of the assembled genome for antibiotic resistance genes and virulence factors, utilizing the CARD and VFDB databases. Notably, the analysis revealed an ab-sence of antibiotic resistance or virulence factors in Dietzia natronolimnaea C79793-74. The safety and tol-erability of D. natronolimnaea C79793-74 were further investigated in an 8-week double-blind, place-bo-controlled clinical trial involving healthy adult participants. A daily dose of 5 x 109 CFU of the probiotic strain was administered. This clinical trial represents the first assessment of the safety of D. natronolimnaea C79793-74 in human subjects. Results demonstrated that participants in both the Dietzia and Placebo groups maintained clinical and hematologic markers within the normal range throughout the study. More-over, the probiotic strain was well-tolerated, with nearly all participants experiencing no severe or medium adverse events. Collectively, the comprehensive data obtained in this study support the inference that Dietzia natronolimnaea C79793-74 is safe and well-tolerated as a nutritional supplement for human con-sumption

Keywords

dietzia; clinical trial; safety; adverse effect; probiotic

Subject

Medicine and Pharmacology, Complementary and Alternative Medicine

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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