Clinical Trial

A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Impact of CLB101TM️ on Gut Health in Healthy, Overweight Individuals

Completed
View on ClinicalTrials.gov →
Summary
Anaerostipes caccae CLB101TM️ is a next-generation probiotic isolated from healthy humans. It was shown to be in decreased abundance in people with protein-based food sensitivities/allergies. CLB101TM️ is different from most commercially available probiotics in that it directly produces butyrate. Butyrate is a naturally occurring small molecule found in the gut of healthy individuals, and it has been shown to provide clinical benefits including strengthening the gut lining, providing immune health, and supporting a balanced microbiome. The rationale for developing CLB101TM️ is to provide a probiotic that generates butyrate in the targeted intestinal locations where it can optimally benefit cells that line the gut.
Protocol Amendment History 3 changes
critical Trial status changed: Enrolling by Invitation → Completed 2026-08-14
notable Enrollment increased: 48 -> 85 participants 2026-08-14
notable Primary completion pushed: 2026-04-26 -> 2026-06-23 2026-08-14
Trial Details
NCT Number NCT07336615
Lead Sponsor ClostraBio Inc.
Conditions Gastrointestinal, Overweight , Obesity
Enrollment 85 participants
Start Date 2025-10-09
Primary Completion 2026-06-23 (estimated)
Study Completion 2026-06-23 (estimated)
Updated on ClinicalTrials.gov 2026-08-13