ClostraBio Announces Positive Results in Landmark Clinical Study with Next-Generation Probiotic CLB101™ and NutraIngredients USA 2026 Award

CHICAGO--(BUSINESS WIRE)--ClostraBio, a biotechnology company developing next-generation probiotics to support gut health, today announced the completion of the first randomized, double-blind, placebo-controlled human clinical study evaluating its next-generation probiotic strain, Anaerostipes caccae CLB101™. The study achieved both the primary safety and tolerability endpoint while also demonstrating statistically significant differences in key secondary efficacy endpoints.

The clinical study examined CLB101™, a first-in-class butyrate-producing probiotic, in a four-week, randomized, controlled design to evaluate the safety and tolerability of CLB101™, while also generating insight into its potential to impact gut health. The study incorporated multiple efficacy endpoints including subject-reported outcomes based on the validated Gastrointestinal Symptom Rating Scale (GSRS), and multiple exploratory biomarkers.

“We are thrilled with the topline results of the first ever gold-standard clinical study conducted with CLB101™," said Ritu Shah, CEO of ClostraBio. “As an incredibly unique, strict anaerobe isolated from healthy humans and known to directly product butyrate in the lower gut, CLB101™ represents true innovation in the probiotic industry. Our current customer testimonials have already demonstrated that the product is helping many people overcome significant gut health challenges, and these clinical study data are further validation. We look forward to sharing complete study results upon publication of the data in a peer-reviewed journal.”

Additionally, the industry has now recognized the novelty and clinical importance of CLB101™: Anaerostipes Probiotic, commercialized by Designs for Health and the first product containing the CLB101™ active ingredient, won “Product of the Year: Microbiome Modulation” at the 2026 NutraIngredients USA Awards. Described as the dietary supplement industry’s most coveted awards ceremony, the 2026 NIU Awards took place on Monday, July 13^th in Chicago, and also saw ClostraBio nominated as one of three finalists for Start-Up of the year.

"When we decided to be the first to bring CLB101™ to market, it was because the science behind it was unlike anything else available in the practitioner channel," said Jonathan Lizotte, Founder and Executive Chairman of Designs for Health. "Winning Product of the Year at the NutraIngredients USA Awards, alongside the completion of ClostraBio's clinical study, is a proud moment for both of our companies and a clear signal that next-generation probiotic science is exactly what practitioners and their patients have been waiting for."

About ClostraBio:

ClostraBio is leveraging a science driven, multi-pronged approach to address conditions of the lower gut, using novel biotechnology to harness natural pathways. The Company has commercialized a next-generation probiotic, CLB101™ that produces butyrate in the lower gut to impact intestinal barrier function and promote gut health*, and is developing a novel polymeric prodrug platform designed to deliver small molecules to the lower gut. ClostraBio was spun out of the University of Chicago and is incubated at Portal Innovations.

About Anaerostipes caccae CLB101™:

A next-generation probiotic strain isolated from healthy humans, CLB101™ is unique and highly differentiated from traditional probiotics in that as a strict anaerobe, it has capacity to directly produce butyrate to impact gut barrier integrity, immunity and microbiome balance*. CLB101™ has achieved self-affirmed GRAS status, demonstrated clinical efficacy, and is currently marketed in the US as a dietary supplement. https://clb101probiotic.com/

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.