Chicago biotech startup ClostraBio has secured GRAS (Generally Recognized as Safe) status for its flagship probiotic ingredient CLB101™, clearing the path for the first commercially available strain of Anaerostipes caccae in the U.S.

What Makes It Different

Unlike traditional probiotics, CLB101™ produces butyrate directly in the lower intestine. This beneficial compound strengthens the intestinal barrier, supports immune function, and promotes a diverse microbiome—all critical for gut health.

The strain, isolated from healthy humans, underwent rigorous safety testing including genomic characterization and multiple toxicology studies before receiving expert panel approval.

Market Launch

ClostraBio plans to launch CLB101™ as a supplement this fall through direct sales and partnerships, including a collaboration with a leading healthcare practitioner-focused brand.

“This recognition reinforces our commitment to advancing safe, science-driven solutions that can help support gut health,” said CEO Ritu Shah.

Spun out from the University of Chicago, ClostraBio’s first-to-market advantage with Anaerostipes caccae positions it well as consumers increasingly seek targeted, research-backed gut health solutions.