Establishing Effects of Bacillus Clausii Probiotic Consumption on Gastrointestinal Health and Inflammation

Part of paid clinical trials in Fort Collins, Colorado.

Sponsor
Colorado State University
Study ID
NCT07618026
Status
Completed

Conditions

  • Gastrointestinal Health

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Bacillus (Shouchella) clausii CSI08 — DIETARY_SUPPLEMENT
    Gram-positive, spore-forming microorganism
  • Placebo — OTHER
    Inert filler material delivered in a capsule identical to the probiotic intervention

Study Details

The study is a randomized, double-blind, crossover, placebo-controlled clinical intervention trial to test the effects of a commercial Bacillus (Shouchella) clausii probiotic compared to a placebo on gastrointestinal symptoms.

Key Dates

Start date
Mar 28, 2024
Status verified
May 2026
Primary completion
Mar 31, 2025
Completion
Mar 31, 2025

Study Design

Enrollment
55 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Bacillus (Shouchella) clausii
    1x10\^9 CFU of Bacillus clausii CSI08 provided in a 300 mg capsule with a rice maltodextrin and coconut triglycerides mixture as the filler.
  • Placebo Comparator: Placebo
    The placebo was a 300mg capsule containing a rice maltodextrin and coconut triglycerides mixture.

Primary Outcome Measure

Adverse Event Rate [ Time Frame: 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Food and Nutrition Clinical Research LaboratoryFort CollinsColorado80523-

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Food and Nutrition Clinical Research Laboratory· Fort Collins, CO

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