Probiotic strain from ClostraBio obtains self-affirmed GRAS status

In a July 29, 2025, press release¹, biotechnology company ClostraBio, Inc. announced the self-affirmed Generally Recognized as Safe (GRAS) status of its probiotic strain, Anaerostipes caccae CLB101.

As the press release explains, CLB101 is a strict anaerobe that has been isolated from a healthy human and supports production of molecule butyrate in the lower intestine, which offers gut health benefits through strengthening intestinal barrier function, immune support, and enhancing microbiome diversity. ClostraBio stated the strain is anticipated to be released as a supplement probiotic supplement in Fall of this year.

The GRAS status had been granted by a panel of scientific experts reviewing safety data of toxicology studies, genomic characterization, and more, plus the manufacturing process, the press release also reported. The status is a step towards introduction in the U.S. market as a commercially available strain of Anaerostipes caccae.

“Receiving GRAS status marks a critical milestone for ClostraBio and validates the safety of CLB101 as we move towards commercial launch,” stated Ritu Shah, CEO of ClostraBio, in the press release. “This recognition reinforces our commitment to advancing safe, science-driven solutions that can help support gut health for the many people who are struggling today.”

Reference

1. ClostraBio, Inc. ClostraBio, Inc. Obtains Self-Affirmed GRAS Status for Next-Gen Probiotic Ingredient CLB101™ https://www.businesswire.com/news/home/20250729574134/en/ClostraBio-Inc.-Obtains-Self-Affirmed-GRAS-Status-for-Next-Gen-Probiotic-Ingredient-CLB101 (accessed 2025-07-30).