プロバイオティクスと健康に関するジャーナル
オープンアクセス

概要

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

Gissel García, Josanne Soto, Jesus Barreto, Angela Gutiérrez, Carmen Soto, Ana Beatriz Pérez, Judith Peña, Raúl J. Cano

Dietzia natronolimnaea C79793-74 have been identified as of potential probiotic strain for the management of Crohn's disease in humans. The following research presents a series of studies that establish the safety profile of this strain for use as a probiotic supplement. The genotypic characterization of Dietzia natronolimnaea C79793-74 was conducted through a combination of 16S rRNA analysis and genomic sequencing and the analysis was conducted using MiGA and MyTaxa. The safety study also involved a search of the assembled genome for the presence of antibiotic resistance genes and virulence factors using the Curated Database of Antibiotic Resistance genes (CARD) and Virulence Factor Database (VFDB) databases, respectively. Notably, Dietzia natronolimnaea C79793-74 exhibited no evidence of antibiotic resistance or virulence factors in the analysis. The utilization of D. natronolimnaea C79793- 74 as a probiotic was evaluated in an 8-week double-blind, placebo-controlled clinical trial, wherein a daily dose of 5 × 10⁹ Colony Forming Unit (CFU) per capsule was administered to a group of healthy adult participants. This study represents the first instance in which the safety and tolerability of Dietzia natronolimnaea C79793-74 were assessed in human subjects. The results revealed that all participants, both in the dietzia and placebo groups maintained clinical and hematologic markers measured within the normal range throughout the study. Additionally, nearly all the study participants tolerated the probiotic strain well and no medium or serious adverse events were observed when compared to the placebo group. Based on the sum total of all the data obtained in this study it can be inferred that D. natronolimnaea strain C79793-74 is safe as a nutritional supplement for humans.