NCT07388264 · Lindenwood University
Impact of Weizmannia (Bacillus) Coagulans JBI-YZ6.3 on Gut Health and Fecal Microbiome Changes
(WIZ)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Saint Charles, Missouri
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 5, 2026 · Source of record for eligibility and locations