Impact of Weizmannia (Bacillus) Coagulans JBI-YZ6.3 on Gut Health and Fecal Microbiome Changes (NCT07388264) | Clinical Trial Compass
RecruitingNot Applicable
Impact of Weizmannia (Bacillus) Coagulans JBI-YZ6.3 on Gut Health and Fecal Microbiome Changes
United States30 participantsStarted 2025-06-15
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Curr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.