Gastrointestinal SymptomsWIZNCT07388264
Impact of Weizmannia (Bacillus) Coagulans JBI-YZ6.3 on Gut Health and Fecal Microbiome Changes
A study testing Weizmannia (Bacillus) coagulans JBI-YZ6.3 in people with Gastrointestinal Symptoms and Constipation, run by Lindenwood University at 1 site in United States.
Trial summary
This study will evaluate the effects of supplementation with Weizmannia (Bacillus) coagulans JBI-YZ6.3 on gastrointestinal health in healthy, physically active adults. The primary objective is to determine whether daily intake of this probiotic strain improves symptoms of constipation and related gastrointestinal… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Symptoms, Constipation, Gut Health
- What is being tested?
- Weizmannia (Bacillus) coagulans JBI-YZ6.3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2025to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion Criteria Ages of 18 - 50 years Average daily bloating score >5 on question 3 of the Modified daily Abdominal, Gas, and Bloating Questionnaire and/or bloating for >5 days during the past 14 days Body mass index (BMI) 18.5 - 29.9 kg/m2 (Inclusive) (Individuals >29.9 kg/m2, but <25% fat for men and <30% fat for women will be accepted into the study. The cohort average of body mass index will not exceed 29.9 kg/m2) Weight stable for the past three months (defined as less than a 5% variation in body mass over this time) Determined to be healthy through completion of a health history questionnaire Subject agrees to maintain their existing dietary patterns throughout the study period and to report to study investigators any changes particularly as they relate to probiotic-containing or fermented foods Subject agrees to refrain from alcohol, caffeine, and strenuous exercise for 24 hours prior to each test day.
Minimum baseline physical activity level (defined as at least 30 minutes of moderate intensity exercise at least 4 days per week for the past 3 months) Subject is willing and able to comply with the study protocol. Study participant is not currently enrolled in another clinical trial that involves the administration of some investigative agent Subject has given voluntary, written, informed consent to participate in the study.
Exclusion Criteria Positive medical history and/or is currently being treated for some form of heart disease, cardiovascular disease Currently being treated for kidney disease, renal failure, or has dialysis performed on regular intervals Has liver disease or some form of clinically diagnosed hepatic impairment Diagnosed with having Type I or Type II diabetes (determined as fasting blood glucose > 126 mg/dL) Diagnosed with or is being treated for some form of thyroid disease Diagnosed with major affective disorder or other psychiatric disorder that required hospitalization in the prior year Diagnosed with some form of immune disorder (i.e., HIV/AIDS) History of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit).
Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea) Participant has been treated for a gastrointestinal related disorder, complication, or disorder within the past 30 days Positive medical history for any neurological condition or neurological disease Diagnosed with or being treated for any endocrinological disorder or currently used any form of hormone replacement (prescribed/doctor ordered or not) Women with a history of hormone-related conditions such as endometriosis, fibroids, polycystic ovary syndrome Currently prescribed for the first time statin drugs (i.e., Lipitor, Livalo, Crestor, Zocor, etc.) within the past 6 months or has had their dosage or medication changed within the past 6 months Currently prescribed for the first time hypertension medication (i.e., Beta-blockers, ACE Inhibitors, Alpha blockers, Vasodilators, etc.) within the past 6 months or has had their dosage or medication changed within the past 6 months Current antibiotic use or other prescription or over-the-counter medications that may impact study outcomes Have a known sensitivity or allergy to any of the study products Blood donation in past 60 days Current smoker (average of > 1 pack per week within the past 3 months) or has quit within the past six months. This includes all forms of nicotine They plan major changes in lifestyle (i.e., diet, dieting, exercise level, travel, etc.) during the study Competitive athletes will be excluded History of alcohol or substance abuse in the 12 months prior to screening Current use of anabolic steroids (medically prescribed or otherwise) Receipt or use of an investigational product in another research study within 30 days of beginning the study protocol Report taking a probiotic or other dietary supplement know to impact digestion or gut function in the past 30 days Recent history (<3 months) of exercise training or weight loss (> 5%) Currently following a ketogenic or low carbohydrate diet within the past 30 days.
Women who are pregnant, planning to become pregnant, or lactating currently or within the past six months Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Lindenwood University
Saint Charles, Missouri, 63301
Anthony M Hagele, MS, 6369494785, ahagele@lindenwood.edu
Joesi M Krieger, MS, 6369494785, jmorey@lindenwood.edu
About this study
Official title: Examining the Impact of Weizmannia (Bacillus) Coagulans JBI-YZ6.3 on Gut Health and Fecal Microbiome Changes
This study will evaluate the effects of supplementation with Weizmannia (Bacillus) coagulans JBI-YZ6.3 on gastrointestinal health in healthy, physically active adults. The primary objective is to determine whether daily intake of this probiotic strain improves symptoms of constipation and related gastrointestinal function compared with placebo.
Approximately 30 healthy men and women aged 18 to 50 years will be enrolled in a randomized, double-blind, placebo-controlled, crossover trial. Participants will complete two 4-week supplementation periods, one with Weizmannia (Bacillus) coagulans JBI-YZ6.3 and one with placebo, separated by a 4-week washout period. The total duration of participation will be approximately 13 to 14 weeks, including screening and testing visits.
Read more
Gastrointestinal symptoms will be assessed at baseline and after each supplementation period using validated questionnaires, with particular focus on the constipation domain of the Gastrointestinal Symptom Rating Scale (GSRS). Secondary outcomes will include additional gastrointestinal symptom domains and markers of perceived gut comfort and function.
This study is designed to determine whether supplementation with Weizmannia (Bacillus) coagulans JBI-YZ6.3 produces clinically meaningful improvements in gastrointestinal symptoms in physically active adults compared with placebo.
Read the detailed description
This study is designed to examine the effects of supplementation with Weizmannia (Bacillus) coagulans JBI-YZ6.3 on gastrointestinal health in healthy, physically active adults. Probiotic supplementation has been shown to influence gastrointestinal symptoms, intestinal barrier function, and microbial composition, but responses vary depending on strain, dose, and population. Weizmannia (Bacillus) coagulans JBI-YZ6.3 is a spore-forming probiotic strain that is highly stable and may survive gastric transit, allowing for potential effects on gut function and symptom perception. However, controlled clinical data in physically active adults are limited.
This study will employ a randomized, double-blind, placebo-controlled, crossover design to compare the effects of JBI-YZ6.3 with placebo. Approximately 30 healthy men and women aged 18 to 50 years will be recruited. All participants will be physically active and free of diagnosed gastrointestinal, metabolic, or inflammatory diseases.
After completing an online screening visit, eligible participants will complete two 4-week supplementation periods. During one period, participants will consume a daily dose of Weizmannia (Bacillus) coagulans JBI-YZ6.3, and during the other period they will consume a matched placebo. The order of treatments will be randomized. A 4-week washout period will separate the two supplementation phases to minimize any potential carryover effects. Participants will attend laboratory or virtual testing visits at the start and end of each supplementation period (weeks 0 and 4 of each phase).
Throughout the study, participants will be instructed to maintain their habitual diet, physical activity, and lifestyle behaviors, and to refrain from consuming additional probiotic or prebiotic supplements. Compliance with supplementation will be monitored by self-report and returned capsule counts.
The primary outcome of this study is the constipation domain of the Gastrointestinal Symptom Rating Scale (GSRS), a validated questionnaire used to assess gastrointestinal symptom severity. Secondary outcomes will include additional GSRS domains and other self-reported measures of gastrointestinal comfort and function.
Safety will be monitored throughout the study by collection of self-reported adverse events at each testing visit and via weekly check-ins during supplementation periods.
This study will determine whether daily supplementation with Weizmannia (Bacillus) coagulans JBI-YZ6.3 improves constipation-related symptoms and overall gastrointestinal health in physically active adults compared with placebo.
- Being tested
- Weizmannia (Bacillus) coagulans JBI-YZ6.3, Placebo
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weizmannia (Bacillus) coagulans JBI-YZ6.3Dietary supplement
Participants will ingest Weizmannia (Bacillus) coagulans JBI-YZ6.3 daily for 4 weeks. The supplement will be provided in capsule form and consumed once daily with approximately eight ounces of water. Participants will be instructed to consume the supplement at the same time each day. If a dose is missed, participants will be instructed to take the missed dose the following day by splitting the dose into one capsule in the morning and one capsule in the evening. Supplementation will occur during one of two 4-week intervention periods as part of a randomized, double-blind, placebo-controlled crossover design.
PlaceboDietary supplement
Participants will ingest a placebo consisting of microcrystalline cellulose in capsule form for 4 weeks. The placebo capsules will be identical in size, color, and appearance to the active supplement. Participants will consume the placebo once daily with approximately eight ounces of water at the same time each day. If a dose is missed, participants will be instructed to take the missed dose the following day by splitting the dose into one capsule in the morning and one capsule in the evening. Placebo supplementation will occur during one of two 4-week intervention periods as part of a randomized, double-blind, placebo-controlled crossover design
| Study group | Role | What they receive |
|---|---|---|
| Weizmannia (Bacillus) coagulans JBI-YZ6.3 | Experimental | Not described Receives: Dietary Supplement: Weizmannia (Bacillus) coagulans JBI-YZ6.3 |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constipation Score (Gastrointestinal Symptom Rating Scale)
Constipation will be assessed using the constipation domain of the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS is a validated 15-item questionnaire scored on a 7-point Likert scale, where higher scores indicate greater symptom severity. The constipation domain includes items related to hard stools, constipation, and sensation of incomplete bowel emptying. Scores will be compared between the Weizmannia (Bacillus) coagulans JBI-YZ6.3 and placebo conditions.
Measured: Baseline and end of each 4-week supplementation period (Weeks 0 and 4 of each intervention period)
Secondary outcomes (3)
Total GSRS Score
Overall gastrointestinal symptom severity will be assessed using the total score of the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS includes 15 items rated on a 7-point Likert scale assessing gastrointestinal symptoms over the past week.
Measured: Baseline and end of each 4-week supplementation period
GSRS Symptom Domain Scores
Individual GSRS domain scores for diarrhea, indigestion, abdominal pain, and reflux will be calculated and compared between the probiotic and placebo conditions.
Measured: Baseline and end of each 4-week supplementation period
Stool Consistency (Bristol Stool Chart)
Stool consistency will be assessed using the Bristol Stool Chart, which classifies stool form into seven categories ranging from hard pellets to watery stool. Scores will be compared between supplementation conditions.
Measured: Baseline, mid-intervention (Week 2 of each period), and end of each 4-week supplementation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start15 Jun 2025
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal SymptomsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study uses a randomized, double-blind, placebo-controlled, crossover design. All participants will receive both interventions in a randomized order. Each participant will complete two 4-week supplementation periods, one with Weizmannia (Bacillus) coagulans JBI-YZ6.3 and one with placebo, separated by a 4-week washout period to minimize potential carryover effects. Participants will be randomly assigned to one of two treatment sequences: probiotic followed by placebo, or placebo followed by probiotic. Randomization will be stratified by sex, age, and body mass index. Both participants and study personnel will remain blinded to treatment assignment for the duration of the study. All participants will serve as their own control, allowing within-subject comparisons of gastrointestinal symptoms, stool characteristics, and fecal microbiome outcomes between the probiotic and placebo conditions.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lindenwood University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chad M Kerksick, PhD, Principal investigator, Lindenwood University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388264
- Sponsor's protocol ID
- IRB-25-41
- Acronym
- WIZ
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data contain sensitive longitudinal biological and symptom information that cannot be reliably de-identified without compromising participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of Weizmannia (Bacillus) Coagulans JBI-YZ6.3 on Gut Health and Fecal Microbiome Changes
- ClinicalTrials.gov ID
- NCT07388264
- Acronym / sponsor ID
- WIZ / IRB-25-41
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Lindenwood UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 5 Feb 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.
This study will evaluate the effects of supplementation with Weizmannia (Bacillus) coagulans JBI-YZ6.3 on gastrointestinal health in healthy, physically active adults. The primary objective is to determine whether daily intake of this probiotic strain improves symptoms of constipation and related gastrointestinal function compared with placebo.
Approximately 30 healthy men and women aged 18 to 50 years will be enrolled in a randomized, double-blind, placebo-controlled, crossover trial. Participants will complete two 4-week supplementation periods, one with Weizmannia (Bacillus) coagulans JBI-YZ6.3 and one with placebo, separated by a 4-week washout period. The total duration of participation will be approximately 13 to 14 weeks, including screening and testing visits.
Gastrointestinal symptoms will be assessed at baseline and after each supplementation period using validated questionnaires, with particular focus on the constipation domain of the Gastrointestinal Symptom Rating Scale (GSRS). Secondary outcomes will include additional gastrointestinal symptom domains and markers of perceived gut comfort and function.
This study is designed to determine whether supplementation with Weizmannia (Bacillus) coagulans JBI-YZ6.3 produces clinically meaningful improvements in gastrointestinal symptoms in physically active adults compared with placebo.
Detailed description
This study is designed to examine the effects of supplementation with Weizmannia (Bacillus) coagulans JBI-YZ6.3 on gastrointestinal health in healthy, physically active adults. Probiotic supplementation has been shown to influence gastrointestinal symptoms, intestinal barrier function, and microbial composition, but responses vary depending on strain, dose, and population. Weizmannia (Bacillus) coagulans JBI-YZ6.3 is a spore-forming probiotic strain that is highly stable and may survive gastric transit, allowing for potential effects on gut function and symptom perception. However, controlled clinical data in physically active adults are limited.
This study will employ a randomized, double-blind, placebo-controlled, crossover design to compare the effects of JBI-YZ6.3 with placebo. Approximately 30 healthy men and women aged 18 to 50 years will be recruited. All participants will be physically active and free of diagnosed gastrointestinal, metabolic, or inflammatory diseases.
After completing an online screening visit, eligible participants will complete two 4-week supplementation periods. During one period, participants will consume a daily dose of Weizmannia (Bacillus) coagulans JBI-YZ6.3, and during the other period they will consume a matched placebo. The order of treatments will be randomized. A 4-week washout period will separate the two supplementation phases to minimize any potential carryover effects. Participants will attend laboratory or virtual testing visits at the start and end of each supplementation period (weeks 0 and 4 of each phase).
Throughout the study, participants will be instructed to maintain their habitual diet, physical activity, and lifestyle behaviors, and to refrain from consuming additional probiotic or prebiotic supplements. Compliance with supplementation will be monitored by self-report and returned capsule counts.
The primary outcome of this study is the constipation domain of the Gastrointestinal Symptom Rating Scale (GSRS), a validated questionnaire used to assess gastrointestinal symptom severity. Secondary outcomes will include additional GSRS domains and other self-reported measures of gastrointestinal comfort and function.
Safety will be monitored throughout the study by collection of self-reported adverse events at each testing visit and via weekly check-ins during supplementation periods.
This study will determine whether daily supplementation with Weizmannia (Bacillus) coagulans JBI-YZ6.3 improves constipation-related symptoms and overall gastrointestinal health in physically active adults compared with placebo.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a randomized, double-blind, placebo-controlled, crossover design. All participants will receive both interventions in a randomized order. Each participant will complete two 4-week supplementation periods, one with Weizmannia (Bacillus) coagulans JBI-YZ6.3 and one with placebo, separated by a 4-week washout period to minimize potential carryover effects. Participants will be randomly assigned to one of two treatment sequences: probiotic followed by placebo, or placebo followed by probiotic. Randomization will be stratified by sex, age, and body mass index. Both participants and study personnel will remain blinded to treatment assignment for the duration of the study. All participants will serve as their own control, allowing within-subject comparisons of gastrointestinal symptoms, stool characteristics, and fecal microbiome outcomes between the probiotic and placebo conditions.
| Arm | Type | Receives |
|---|---|---|
| Weizmannia (Bacillus) coagulans JBI-YZ6.3 | Experimental | Dietary Supplement: Weizmannia (Bacillus) coagulans JBI-YZ6.3 |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Weizmannia (Bacillus) coagulans JBI-YZ6.3Participants will ingest Weizmannia (Bacillus) coagulans JBI-YZ6.3 daily for 4 weeks. The supplement will be provided in capsule form and consumed once daily with approximately eight ounces of water. Participants will be instructed to consume the supplement at the same time each day. If a dose is missed, participants will be instructed to take the missed dose the following day by splitting the dose into one capsule in the morning and one capsule in the evening. Supplementation will occur during one of two 4-week intervention periods as part of a randomized, double-blind, placebo-controlled crossover design. | Dietary supplement | Weizmannia (Bacillus) coagulans JBI-YZ6.3 |
| PlaceboParticipants will ingest a placebo consisting of microcrystalline cellulose in capsule form for 4 weeks. The placebo capsules will be identical in size, color, and appearance to the active supplement. Participants will consume the placebo once daily with approximately eight ounces of water at the same time each day. If a dose is missed, participants will be instructed to take the missed dose the following day by splitting the dose into one capsule in the morning and one capsule in the evening. Placebo supplementation will occur during one of two 4-week intervention periods as part of a randomized, double-blind, placebo-controlled crossover design | Dietary supplement | Placebo |
Primary outcome
Constipation Score (Gastrointestinal Symptom Rating Scale)
Time frame: Baseline and end of each 4-week supplementation period (Weeks 0 and 4 of each intervention period)
Constipation will be assessed using the constipation domain of the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS is a validated 15-item questionnaire scored on a 7-point Likert scale, where higher scores indicate greater symptom severity. The constipation domain includes items related to hard stools, constipation, and sensation of incomplete bowel emptying. Scores will be compared between the Weizmannia (Bacillus) coagulans JBI-YZ6.3 and placebo conditions.
3 secondary outcomes
Total GSRS Score
Time frame: Baseline and end of each 4-week supplementation period
GSRS Symptom Domain Scores
Time frame: Baseline and end of each 4-week supplementation period
Stool Consistency (Bristol Stool Chart)
Time frame: Baseline, mid-intervention (Week 2 of each period), and end of each 4-week supplementation period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No. Data contain sensitive longitudinal biological and symptom information that cannot be reliably de-identified without compromising participant privacy.
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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.
Chad M Kerksick, PhD principal investigator
Lindenwood University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weizmannia (Bacillus) coagulans JBI-YZ6.3 in people with Gastrointestinal Symptoms and Constipation, run by Lindenwood 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?
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: looking for participants now, as of the sponsor's last update on 5 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anthony M Hagele, MS (6369494785, ahagele@lindenwood.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constipation Score (Gastrointestinal Symptom Rating Scale) (time frame: Baseline and end of each 4-week supplementation period (Weeks 0 and 4 of each intervention period)). 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 5 Feb 2026.