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

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

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Health
• Intervention / Treatment: Dietary supplement: Bacillus (Shouchella) clausii CSI08; Other: Placebo

Detailed Description

Prospective participants are pre-qualified by email screening and attended an in-person study visit at Colorado State University's Food and Nutrition Clinical Research Laboratory (FNCRL) in the Department of Food Science and Human Nutrition. During the initial visit, participants signed the Consent Form after the nature of the procedure had been fully explained to them. Their eligibility is confirmed by taking anthropometric measurements of height (cm) and weight (kg) to calculate BMI and by completing a written medical health questionnaire to determine medical history and current medication use. Eligible participants are then assigned sequentially to a study code (MS01, MS02, etc.), and codes were pre-assigned to intervention sequences using a random number generator in Microsoft Excel. For the initial clinic visit (and subsequent visits), participants are fasted for at least 8 hours and asked to abstain from alcohol use for at least 12 hours prior to clinic visits. They were also instructed to refrain from taking any non-prescription medications for 24 hours or dietary supplements for 12 hours before their visits. At the initial visit, a venous blood sample was collected, and participants filled out several assessment forms/questionnaires: GI Health Appraisal Questionnaire, GI Symptom Rating Scale (GSRS), GI Quality of Life Questionnaire (IBS-QOL Questionnaire) 7-day Physical Activity Recall, Positive and Negative Affect Schedule, and Perceived Stress Scale.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Fort Collins, Colorado, United States, 80523
      • Food and Nutrition Clinical Research Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• <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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Dietary supplement: Bacillus (Shouchella) clausii CSI08; Gram-positive, spore-forming microorganism; Other Names: Munispore
Placebo Comparator: Placebo; The placebo was a 300mg capsule containing a rice maltodextrin and coconut triglycerides mixture.	Other: Placebo; Inert filler material delivered in a capsule identical to the probiotic intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiota composition	The gut microbiota composition was assessed by 16s rRNA at the beginning and end of each intervention period.	12 weeks
Systemic Inflammation	PBMCs were collected at the beginning and end of each intervention period and then cultured and stimulated with bacterial LPS. Collected supernatants were assessed using a multiplex ELISA for T-cell activity.	12 weeks
Regularity of Bowel Movements	A Bristol stool scale was used to record daily bowel movements throughout the study to determine changes in bowel movement regularity.	13 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Lipids	Blood lipids were assessed using collected whole blood samples at the beginning and end of each intervention period using a Piccolo Xpress Blood Lipid Panel.	12 weeks
Liver Toxicity	A comprehensive metabolic panel will be performed on whole blood collected at the beginning and end of each intervention period using a Piccolo Xpress Comprehensive Metabolic Panel. This includes multiple markers, that when considered together, can provide an indication of liver toxicity. Specifically, out-of-range values for alanine amino transferase (ALT), asparagine amino transferase (AST), alkaline phosphatase (AST), bilirubin, albumin, and total protein can collectively be interpreted to look for indication of hepatocellular or cholestatic injury.	12 weeks

Collaborators and Investigators

• Sponsor: Colorado State University
• Collaborators: ADM Deerland
• Investigators: Principal Investigator: Tiffany L Weir, PhD, CSU; Study Director: Allegra L Vazquez, MS, CSU

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2024
• Primary Completion (Actual): March 31, 2025
• Study Completion (Actual): March 31, 2025

Study Registration Dates

• First Submitted: February 16, 2026
• First Submitted That Met QC Criteria: May 26, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Intestinal inflammation; Gastrointestinal health
• Other Study ID Numbers: 4176

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No