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

NCT07618026 | Completed

• 1 other identifier: 4176
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrointestinal Health

Keywords

Gastrointestinal health; Intestinal inflammation

Outcome Measures

Primary Outcomes (2)

• Adverse Event Rate

  For each arm adverse event forms were tracked and the total rate of adverse events was calculated

  12 weeks

• Gastrointestinal symptom rating score

  Gastrointestinal symptoms were assessed using the gastrointestinal symptom rating score, at the beginning and end of each intervention period. The GSRS is a 15-item scale where each item can be scored 1-7 according to symptom severity. A minimum score is 15 and the maximum score is 110. The higher score indicates more severe symptoms.

  12 weeks

Secondary Outcomes (3)

• Gut microbiota composition

  12 weeks

• Systemic Inflammation

  12 weeks

• Regularity of Bowel Movements

  13 weeks

Other Outcomes (2)

• Blood Lipids

  12 weeks

• Liver Toxicity

  12 weeks

Study Arms (2)

Bacillus (Shouchella) clausii

EXPERIMENTAL

1x10\^9 CFU of Bacillus clausii CSI08 provided in a 300 mg capsule with a rice maltodextrin and coconut triglycerides mixture as the filler.

Dietary Supplement: Bacillus (Shouchella) clausii CSI08

Placebo

PLACEBO COMPARATOR

The placebo was a 300mg capsule containing a rice maltodextrin and coconut triglycerides mixture.

Other: Placebo

Interventions

Bacillus (Shouchella) clausii CSI08 DIETARY_SUPPLEMENT

Gram-positive, spore-forming microorganism

Also known as: Munispore

Bacillus (Shouchella) clausii

Placebo OTHER

Inert filler material delivered in a capsule identical to the probiotic intervention

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Colorado State University: lead
• ADM Deerland: collaborator

Study Sites (1)

Food and Nutrition Clinical Research Laboratory

Fort Collins, Colorado, 80523, United States

Location

Study Officials

• Tiffany L Weir, PhD

  CSU

  PRINCIPAL INVESTIGATOR

• Allegra L Vazquez, MS

  CSU

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Capsules for the intervention and placebo were produced and coded by ADM Deerland and they held the blinding codes until after the primary outcomes were analyzed.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The trial will be a double-blinded, randomized, placebo-controlled crossover intervention study taking place at Colorado State University.

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: June 1, 2026
• Study Start: March 28, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)