ClostraBio self-affirms GRAS status for next-gen probiotic CLB101

Anaerostipes caccae CLB101 (previously referred to as A. caccae LAHUC) is an obligate, anaerobic bacteria that was isolated from the stool of a healthy infant. The strain has been identified as critical to gut health through its direct production of butyrate in targeted areas of the lower intestine. Butyrate production supports overall microbiome health, with the short-chain fatty acid linked to various health benefits such as strengthening intestinal barrier integrity, immune support and promoting a diverse microbiome. “While the Anaerostipes caccae species is naturally occurring in humans, it is quite differentiated compared to legacy probiotics that are currently on the market," ClostraBio CEO Ritu Shah told NutraIngredients. “Therefore, to ensure safety and following industry-specific regulatory mandates, ClostraBio conducted a complete safety assessment with our specific A. caccae strain.” The safety assessment included genomic characterization, antibiotic resistance examination, manufacturing development and batch analysis and a full battery of in vivo toxicology studies culminating with a 90-day repeat-dose oral toxicity study in rats. Shah noted that all studies in animals demonstrated that the CLB101 strain was safe and well tolerated, even when administered at much higher doses than a human would ingest. Due to manufacturing and stability challenges directly related to individual strains, many of the strict anaerobes or ‘next-generation’ probiotics are not commercializable. Shah said the GRAS affirmation of CLB101 demonstrates this strain is not only safe but can also be manufactured to meet specific quality standards. One challenge plaguing many probiotic producers is getting butyrate to the lower intestine. While butyrate is a widely-studied compound, ensuring its direct delivery to the lower intestine has proven difficult. Shah explained that if taken orally, butyrate will generally be absorbed in the stomach or upper intestine and very little will reach the lower gut where it is produced naturally by strains like CLB101. “Only a small subset of human microbes are direct butyrate producers, and these strains are all strict anaerobes that require complex manufacturing processes that have only recently become commercially viable,” Shah said. “CLB101 is part of an even smaller subset of probiotics that can directly produce butyrate by utilizing acetate and lactate produced by other standard probiotics. This means CLB101 is expected to pair quite well with the many other probiotics that are on the market to provide even greater gut health benefits.” ClostraBio is preparing to launch CLB101 as a probiotic supplement in Fall 2025 through both direct and partnered distribution channels, including a strategic collaboration with a leading healthcare practitioner-focused supplement brand.

ClostraBio self-affirms GRAS status for next-gen probiotic CLB101

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