Weizmannia Coagulans for Gut Health

(WIZ Trial)

Overseen By Joesi M Krieger, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Lindenwood University

Must not be taking: Statins, Hypertension meds, Antibiotics, others

Disqualifiers: Heart disease, Diabetes, Thyroid disease, others

Compensation: Varies

Number of Visits: 5

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a probiotic supplement called Weizmannia coagulans JBI-YZ6.3 to determine its effectiveness in improving gut health, particularly for individuals who frequently experience constipation. Participants will take the probiotic for four weeks and a placebo (a harmless pill without active ingredients) for another four weeks, with a break in between. The trial targets physically active adults who have recently experienced frequent bloating and are generally in good health. The researchers aim to discover if this probiotic can significantly enhance gut comfort and function compared to a placebo. As an unphased trial, it offers participants the chance to contribute to scientific understanding of gut health and potentially improve their own well-being.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those currently using antibiotics or medications that might affect the study outcomes. It's best to discuss your specific medications with the study team.

What prior data suggests that Weizmannia (Bacillus) coagulans JBI-YZ6.3 is safe for gastrointestinal health?

Research has shown that Weizmannia (Bacillus) coagulans JBI-YZ6.3 is safe for humans. This probiotic has undergone thorough study, yielding encouraging results. It is sensitive to various antibiotics, a positive indicator of safety, and lacks harmful genes that could cause issues.

The strain originates from food-grade tapioca starch, a source generally safe for consumption. Experts recognize it as GRAS (Generally Recognized As Safe), further supporting its safety.

Overall, Weizmannia coagulans JBI-YZ6.3 appears well-tolerated, with no major safety concerns reported. Participants in past studies did not experience significant side effects, suggesting it should be safe for most people in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Weizmannia (Bacillus) coagulans JBI-YZ6.3 is unique because it uses a specific strain of probiotics to improve gut health. Unlike traditional treatments for gut health that might involve dietary changes or medications, this probiotic strain is believed to support digestion and balance gut flora naturally. Researchers are excited about this treatment because it offers a potentially safer and more natural way to enhance gut health without the side effects commonly associated with pharmaceutical options. This approach could pave the way for using targeted probiotic strains as a new standard for managing digestive wellness.

What evidence suggests that Weizmannia coagulans could be effective for gut health?

Research shows that Weizmannia (Bacillus) coagulans JBI-YZ6.3, which participants in this trial may receive, may help improve gut health by easing constipation. One study found that a similar strain, Weizmannia coagulans BC99, increased bowel movements and improved stool consistency compared to a placebo. This suggests that the probiotic might regulate digestion and relieve constipation symptoms. Its ability to survive in the stomach and adhere to the gut lining could explain its effectiveness. While more research is needed, early results are promising for those seeking to improve gut health. ^{2 5 6 7 8}

Who Is on the Research Team?

Chad M Kerksick, PhD

Principal Investigator

Lindenwood University

Are You a Good Fit for This Trial?

This trial is for healthy, active adults aged 18-50 with a BMI of 18.5-29.9 who experience regular bloating. Participants must not have had significant weight changes in the past three months and should maintain their usual diet without probiotics or fermented foods during the study.

Inclusion Criteria

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (virtual)

Supplementation Period 1

Participants receive either Weizmannia (Bacillus) coagulans JBI-YZ6.3 or placebo for 4 weeks

4 weeks

2 visits (in-person or virtual)

Washout

A 4-week washout period to minimize carryover effects between supplementation phases

4 weeks

Supplementation Period 2

Participants receive the alternate treatment (either Weizmannia (Bacillus) coagulans JBI-YZ6.3 or placebo) for 4 weeks

4 weeks

2 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Weizmannia (Bacillus) coagulans JBI-YZ6.3

Trial Overview

The trial tests if Weizmannia (Bacillus) coagulans JBI-YZ6.3 improves gut health compared to a placebo over two 4-week periods, separated by a washout phase, in physically active adults experiencing constipation and other gastrointestinal symptoms.

How Is the Trial Designed?

Group I: Weizmannia (Bacillus) coagulans JBI-YZ6.3 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Lindenwood University

Lead Sponsor

Trials

22

Recruited

830+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07388264?term=NA

Impact of Weizmannia (Bacillus) Coagulans JBI-YZ6.3 on ...

This study will evaluate the effects of supplementation with Weizmannia (Bacillus) coagulans JBI-YZ6.3 on gastrointestinal health in healthy ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11306189/

A randomized, double-blind, placebo-controlled clinical study ...

After 4 weeks of treatment, compared to the placebo group, Weizmannia coagulans BC99 effectively elevated the bowel movements, improving stool ...

3.

ctv.veeva.com

ctv.veeva.com/study/impact-of-weizmannia-bacillus-coagulans-jbi-yz63-on-gut-health-and-fecal-microbiome-changes

Impact of Weizmannia (Bacillus) Coagulans JBI-YZ6.3 on Gut ...

This study will determine whether daily supplementation with Weizmannia (Bacillus) coagulans JBI-YZ6.3 improves constipation-related symptoms ...

4.

mdpi.com

mdpi.com/2304-8158/15/4/710

Probiotic Potential of Weizmannia coagulans MA42, an ...

All tested strains exhibited excellent gastrointestinal survival (>90% viability), superior auto-aggregation (up to 36.60%), hydrophobicity (up to 36.58%), and ...

5.

lindenwood.edu

lindenwood.edu/academics/centers-institutes/exercise-and-performance-nutrition-lab-epnl/participate-in-research/effect-of-a-probiotic-on-gut-health-and-fecal-microbiome-changes/

Effect of a Probiotic on Gut Health and Fecal Microbiome ...

The purpose of this study is to examine how supplementation with Weizmannia (Bacillus) coagulans JBI-YZ6.3 affects gut health in healthy, physically active men ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12532747/

Genomic and Phenotypic Safety Assessment of Probiotic ...

coagulans. Antibiotic susceptibility testing showed that the strain JBI-YZ6.3 was sensitive to a panel of fourteen antibiotics, and no genes ...

7.

journals.asm.org

journals.asm.org/doi/10.1128/mra.01003-22

Complete Genomic Sequence of Bacillus coagulans Strain JBI ...

Bacillus coagulans strain JBI-YZ6.3 is a safe probiotic bacterium isolated from food-grade tapioca starch. The complete genome of B.

8.

downloads.regulations.gov

downloads.regulations.gov/FDA-2025-N-1928-0014/attachment_1.pdf

GRAS Notice (GRN) 1263, Bacillus coagulans

The safety assessment for Jeneil's Bacillus coagulans JBI-YZ6.3 (BC4U™) is based on scientific procedures, and thus, experience based on common ...