NCT07388264 Impact of Weizmannia (Bacillus) Coagulans JBI-YZ6.3 on Gut Health and Fecal Microbiome Changes
| NCT ID | NCT07388264 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lindenwood University |
| Condition | Gastrointestinal Symptoms |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-06-15 |
| Primary Completion | 2026-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-06-15 with a primary completion date of 2026-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility 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. 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
Contact & Investigator
Chad M Kerksick, PhD
PRINCIPAL INVESTIGATOR
Lindenwood University
Frequently Asked Questions
Who can join the NCT07388264 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Gastrointestinal Symptoms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07388264 currently recruiting?
Yes, NCT07388264 is actively recruiting participants. Contact the research team at ahagele@lindenwood.edu for enrollment information.
Where is the NCT07388264 trial being conducted?
This trial is being conducted at Saint Charles, United States.
Who is sponsoring the NCT07388264 clinical trial?
NCT07388264 is sponsored by Lindenwood University. The principal investigator is Chad M Kerksick, PhD at Lindenwood University. The trial plans to enroll 30 participants.