NCT07336615

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: ClostraBio Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

The rationale for this study is to observe the impact of a probiotic supplement called CLB101TM️ on gut health in overweight individuals with moderate to severe gastrointestinal discomfort. Additionally, the study aims to observe the impact of the probiotic product on gastrointestinal symptoms, blood parameters, gut microbiota, as well as its impact on intestinal permeability via activities and technologies that can successfully and effectively be completed and utilized in a home setting. A consumer-driven, decentralized observational clinical research study is therefore well-suited for examining the effects of this probiotic product in this population. The study team will examine the outcomes in a broad age-range of adults who have chosen to try this product. The study will incorporate participant reported outcome questionnaires and surveys and at-home stool collection. There is no "doctor-patient" relationship as part of this research since the participant as a consumer is making the informed choice to take the product and take part in the observational process with self-reported measures and at-home sample collection. Findings from this study will contribute knowledge toward the tolerability and formulation of the probiotic product and the design of future studies. This trial includes a parallel sub-study limited to 30 participants. Eligibility criteria for the sub-study are identical to the main cohort, with the exception that biospecimen collection is waived.

Conditions

• Gastrointestinal
• Overweight , Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	CLB101™️	CLB101™️ is a probiotic isolated from healthy humans.
OTHER	Placebo	Placebo control.
DIETARY_SUPPLEMENT	CLB101™️	Sub-study: CLB101™️ is a probiotic isolated from healthy humans.
OTHER	Placebo control	Sub-study: Placebo control.

Timeline

• Start date: 2025-10-09
• Primary completion: 2026-04-26
• Completion: 2026-06-26
• First posted: 2026-01-13
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States