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Updated: Sep 9, 2025
High Content Screening Analysis to Evaluate the Toxicological Effects of Harmful and Potentially Harmful Constituents HPHC
Published on: May 10, 2016
A Comprehensive Toxicological Safety Evaluation of Anaerostipes caccae
Vickie Modica1, Róbert Glávits2, Amy Clewell1
1AIBMR Life Sciences, Inc., Seattle, WA, USA.
Insights
Anaerostipes caccae CLB101, a butyrate-producing bacterium, was evaluated for safety. Studies found no genotoxicity or adverse effects in rats, establishing a No Observed Adverse Effect Level (NOAEL) for human consumption potential.
Area of Science:
- Microbiology and Toxicology
- Gut Microbiome Research
Background:
- Anaerostipes caccae CLB101 is an anaerobic bacterium isolated from infant stool.
- It produces butyrate and may promote microbiome health.
- No prior toxicity data exists for A. caccae strains.
Purpose of the Study:
- To assess the genotoxic and general toxicological potential of A. caccae CLB101.
- To determine safety for potential human consumption.
Main Methods:
- Genotoxicity assessed using in vivo comet and micronucleus assays due to anaerobic nature.
- A 90-day repeated-dose oral toxicity study in Wistar rats (0-1000 mg/kg bw/day).
- Evaluations included clinical signs, body weight, food consumption, clinical pathology, organ weights, and histopathology.
Main Results:
- No evidence of clastogenicity or aneugenicity was found in genotoxicity assays.
- No adverse effects were observed in rats across all tested doses in the 90-day study.
- A No Observed Adverse Effect Level (NOAEL) of 1000 mg/kg bw/day (1.9 × 10^11 CFU/kg bw/day) was established.
Conclusions:
- Anaerostipes caccae CLB101 demonstrates no genotoxic or significant toxicological concerns.
- The study supports the potential safety of A. caccae CLB101 for human consumption.
- A high NOAEL indicates a favorable safety profile for this probiotic candidate.
Abstract:
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 are publicly available for any strain of A. caccae. 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 × 1011 CFU/kg bw/day for all cells and, based on ∼32% cell viability in the buffer used (Mitsuoka), ∼6.1 × 1010 CFU/kg bw/d for living cells.
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