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ClostraBio’s Novel Probiotic Self-Affirmed as GRAS

The probiotic is the first commercially available strain of Anaerostipes caccae, and is slated to launch in the fall.

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By: Mike Montemarano

Associate Editor, Nutraceuticals World

Photo: Dr_Microbe | Adobe Stock

ClostraBio, a company specializing in microbiome-based solutions for gut health, announced that its Anaerostipes caccae CLB101 probiotic was declared to have self-affirmed GRAS (Generally Recognized as Safe) status by a panel of scientific experts. It is the first commercially available strain of its kind.

The anaerobe, isolated from a healthy human, directly produces butyrate in the lower intestine, which supports gut health by strengthening intestinal barrier integrity, modulating immune response, and promoting gut microbiome diversity.

“Receiving GRAS status marks a critical milestone for ClostraBio and validates the safety of CLB101 as we move toward commercial launch,” said Ritu Shah, CEO. “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.”

The GRAS designation came after a safety review which included genomic characterization, toxicology studies, and a review of the manufacturing process and its quality control. ClostraBio will introduce CLB101 as a supplement in the fall, through both direct and partnered distribution channels, including collaborations with healthcare practitioner-focused supplement brands.

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