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

Completed · Not applicable · Has a placebo group

Conditions studied: Gastrointestinal Health

In brief

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 facts

Study ID

NCT07618026

Run by

Colorado State University

People needed

55

Starts

2024-03-28

Expected to finish

2025-03-31

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18-75
• BMI 18-34.9
• self report as healthy
• consistent Mild to Moderate gastrointestinal distress (determined by a functional GI screen)

You may not qualify if…

• <18 or >75
• BMI <18 or >34.9
• antibiotics within two months
• probiotic/prebiotic supplements within two weeks prior to the screening process
• pregnant or breastfeeding
• taking medications that influence study endpoints of the study (i.e., statins, metformin, nonsteroidal anti-inflammatory drugs, and monoamine oxidase inhibitors)
• a current diagnosis of cancer, liver or kidney disease, metabolic disorders, and GI diseases (Celiac disease, inflammatory bowel disease, and peptic ulcer disease)

Where it is running

• Food and Nutrition Clinical Research Laboratory — Fort Collins, Colorado, United States

Full record on ClinicalTrials.gov

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