Bacillus Coagulans Effect on Gastrointestinal Function in Healthy Adults. (NCT06644001) | Clinical Trial Compass
CompletedNot Applicable
Bacillus Coagulans Effect on Gastrointestinal Function in Healthy Adults.
China111 participantsStarted 2021-07-01
Plain-language summary
A single centre, double-blind, placebo-controlled study to evaluate the effect of the consumption of Bacillus coagulans at a daily dose of 1 x 10⁹ CFU on bowel habits, intestinal microbiota and gastrointestinal symptoms in healthy adults.
Who can participate
Age range
18 Years – 65 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.
Exclusion criteria
. Subjects aged \<18 or \> 65 years, pregnant or lactating women, and those who are susceptible to allergens or have food allergies.
. Subjects with cardiovascular, cerebrovascular, hepatic, renal, hematopoietic diseases or endocrine diseases, and or mental illness.
. Subjects with constipation symptoms caused by surgical operation within the past 30 days; subjects with acute GI track diseases in the past 30 days; subjects with constipation symptoms due to severe organ lesion (colon cancer, severe enteritis, intestinal obstruction, inflammatory bowel disease, etc.)
. Subjects who could not eat orally or take the study products as prescribed or cannot comply with the protocol.
. Subjects administered relevant products recently, which would affect the outcome of the study.
. Subjects who took probiotics or prebiotics products (including yogurt, beverages or foods containing probiotics) within the past month, which may affect the results of the study.
. Subjects who suffered from gastrointestinal disease within the past month.
. Subjects who had taken antibiotics in the past month.
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.
What they're measuring
1
Stool frequency
Timeframe: 6 weeks period, from enrollment to the end of the study.
2
Stool consistency.
Timeframe: 6 weeks period, from enrollment to the end of the study.
3
Improvement of constipation rate
Timeframe: 6 weeks period, from enrollment to the end of the study.
4
Improvement in the defection effort
Timeframe: 6 weeks period, from enrollment to the end of the study.
5
Changes in intestinal microbiota
Timeframe: 4 weeks period, assessment at Day 0, Day 14 and Day28
6
Improvement in digestive symptoms scores
Timeframe: 6 weeks; assessment at Day 0, Day 14 and Day 28
7
Improvement in upper GI symptoms
Timeframe: 6 weeks; assessment at Day 0, Day 14 and Day 28