A Comprehensive Toxicological Safety Evaluation of Anaerostipes caccae

CLB101 (CLB101) is an obligate, anaerobic bacteria that was isolated from the stool of a healthy infant. Due to its ability to produce butyrate and its potential promotion of microbiome health through multiple homeostatic interactions there is interest in its consumption by humans. No toxicity data...

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Veröffentlicht in:International journal of toxicology Jg. 44; H. 6; S. 471
Hauptverfasser: Modica, Vickie, Glávits, Róbert, Clewell, Amy, Endres, John R, Hirka, Gábor, Vértesi, Adél, Béres, Erzsébet, Szakonyiné, Ilona Pasics
Format: Journal Article
Sprache:Englisch
Veröffentlicht: United States 01.12.2025
Schlagworte:
Animals
Clostridiales
Comet Assay
Female
Male
Micronucleus Tests
No-Observed-Adverse-Effect Level
Rats
Rats, Wistar
genotoxicity
toxicity
butyrate
Anaerostipes caccae
safety
NOAEL
clostridium cluster XIVa
ISSN:1092-874X
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Zusammenfassung:CLB101 (CLB101) is an obligate, anaerobic bacteria that was isolated from the stool of a healthy infant. Due to its ability to produce butyrate and its potential promotion of microbiome health through multiple homeostatic interactions there is interest in its consumption by humans. No toxicity data are publicly available for any strain of . Therefore, its genotoxic and toxicological potential was investigated in the current study. Due to its anaerobic nature, a genotoxicity evaluation was performed using the in vivo comet assay and the in vivo mammalian micronucleus assay, which found no evidence of clastogenicity or aneugenicity. General toxicity and potential target organs were assessed in a 90-day, repeated-dose, oral toxicity study using 0, 250, 500, and 1000 mg/kg bw/day in Wistar rats. CLB101 exposure did not result in adverse effects in male or female rats when evaluated for clinical signs, body weight, food consumption, clinical pathology, organ weight, and histopathology after administration, at any dose. Therefore, a NOAEL of 1000 mg/kg bw/day, equivalent to 1.9 × 10 CFU/kg bw/day for all cells and, based on ∼32% cell viability in the buffer used (Mitsuoka), ∼6.1 × 10 CFU/kg bw/d for living cells.
ISSN:1092-874X
DOI:10.1177/10915818251367353