Gastrointestinal HealthMUNISPORENCT07618026
Establishing Effects of Bacillus Clausii Probiotic Consumption on Gastrointestinal Health and Inflammation
A study testing Bacillus (Shouchella) clausii CSI08 in people with Gastrointestinal Health, run by Colorado State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Health
- What is being tested?
- Bacillus (Shouchella) clausii CSI08
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-75
- BMI 18-34.9
- self report as healthy
- consistent Mild to Moderate gastrointestinal distress (determined by a functional GI screen)
Who cannot join
- <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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Food and Nutrition Clinical Research Laboratory
Fort Collins, Colorado, 80523
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastrointestinal Health
- Being tested
- Bacillus (Shouchella) clausii CSI08, Placebo
- Keywords
- Gastrointestinal health, Intestinal inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacillus (Shouchella) clausii CSI08Dietary supplement
Also called Munispore
Gram-positive, spore-forming microorganism
PlaceboOther
Inert filler material delivered in a capsule identical to the probiotic intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Bacillus (Shouchella) clausii CSI08 |
| Placebo | Placebo comparator | The placebo was a 300mg capsule containing a rice maltodextrin and coconut triglycerides mixture. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event Rate
For each arm adverse event forms were tracked and the total rate of adverse events was calculated
Measured: 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.
Measured: 12 weeks
Secondary outcomes (3)
Gut microbiota composition
The gut microbiota composition was assessed by 16s rRNA at the beginning and end of each intervention period.
Measured: 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.
Measured: 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.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start28 Mar 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The trial will be a double-blinded, randomized, placebo-controlled crossover intervention study taking place at Colorado State University.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- ADM Deerland
- Responsible party
- Sponsor
- Investigators
- Tiffany L Weir, PhD, Principal investigator, CSUAllegra L Vazquez, MS, Study director, CSU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618026
- Sponsor's protocol ID
- 4176
- Acronym
- MUNISPORE
- Status last verified
- May 2026
- First submitted
- 16 Feb 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MUNISPORE: Establishing Effects of Bacillus Clausii Probiotic Consumption on Gastrointestinal Health and Inflammation
- ClinicalTrials.gov ID
- NCT07618026
- Acronym / sponsor ID
- MUNISPORE / 4176
- Conditions
- Gastrointestinal Health
- Keywords
- Gastrointestinal health, Intestinal inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- ADM Deerland
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The trial will be a double-blinded, randomized, placebo-controlled crossover intervention study taking place at Colorado State University.
| Arm | Type | Receives |
|---|---|---|
| Bacillus (Shouchella) clausii | Experimental | Dietary Supplement: Bacillus (Shouchella) clausii CSI081x10^9 CFU of Bacillus clausii CSI08 provided in a 300 mg capsule with a rice maltodextrin and coconut triglycerides mixture as the filler. |
| Placebo | Placebo comparator | Other: PlaceboThe placebo was a 300mg capsule containing a rice maltodextrin and coconut triglycerides mixture. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-75
- BMI 18-34.9
- self report as healthy
- consistent Mild to Moderate gastrointestinal distress (determined by a functional GI screen)
Key exclusion criteria (7 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacillus (Shouchella) clausii CSI08Also: MunisporeGram-positive, spore-forming microorganism | Dietary supplement | Bacillus (Shouchella) clausii |
| PlaceboInert filler material delivered in a capsule identical to the probiotic intervention | Other | Placebo |
Primary outcome
Adverse Event Rate
Time frame: 12 weeks
For each arm adverse event forms were tracked and the total rate of adverse events was calculated
Gastrointestinal symptom rating score
Time frame: 12 weeks
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.
3 secondary outcomes
Gut microbiota composition
Time frame: 12 weeks
Systemic Inflammation
Time frame: 12 weeks
Regularity of Bowel Movements
Time frame: 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiffany L Weir, PhD principal investigator
CSU
Allegra L Vazquez, MS study director
CSU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bacillus (Shouchella) clausii CSI08 in people with Gastrointestinal Health, run by Colorado State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event Rate (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.