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

NCT07336615 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-03-23

No results posted yet for this study

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.

Conditions

  • Gastrointestinal
  • Overweight , Obesity

Interventions

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.

Sponsors & Collaborators

  • ClostraBio Inc.

    lead INDUSTRY

Principal Investigators

  • Naoh Craft, MD · People Science

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-09
Primary Completion
2026-04-26
Completion
2026-06-26

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07336615 on ClinicalTrials.gov