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

Part of paid clinical trials in Los Angeles, California.

Sponsor
ClostraBio Inc.
Study ID
NCT07336615
Status
Enrolling By Invitation

Conditions

  • Gastrointestinal
  • Overweight , Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • CLB101™️ — DIETARY_SUPPLEMENT
    CLB101™️ is a probiotic isolated from healthy humans.
  • Placebo — OTHER
    Placebo control.
  • CLB101™️ — DIETARY_SUPPLEMENT
    Sub-study: CLB101™️ is a probiotic isolated from healthy humans.
  • Placebo control — OTHER
    Sub-study: Placebo control.

Study Details

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.

Key Dates

Start date
Oct 9, 2025
Status verified
Mar 2026
Primary completion
Apr 26, 2026
Completion
Jun 26, 2026

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Study product CLB101
    Study group will receive the study product CLB101
  • Placebo Comparator: Placebo control
    Placebo control group will only receive the placebo until the end of study.
  • Experimental: Sub-Study CLB101 Arm
    Study group will receive the study product CLB101
  • Placebo Comparator: Sub-Study Placebo Control
    Placebo control group will only receive the placebo until the end of study.

Primary Outcome Measure

Adverse Events [ Time Frame: 6 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
People ScienceLos AngelesCalifornia90034-

Find similar trials in Los Angeles, CA

By research site
People Science· Los Angeles, CA

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