Actively Recruiting
Examining the Impact of Weizmannia (Bacillus) Coagulans JBI-YZ6.3 on Gut Health and Fecal Microbiome Changes
Led by Lindenwood University · Updated on 2026-02-05
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a daily probiotic supplement called Weizmannia (Bacillus) coagulans JBI-YZ6.3 on gut health in healthy, physically active adults aged 18 to 50 years. The study aims to find out if this probiotic can improve constipation symptoms and overall gastrointestinal function compared to a placebo. It is a randomized, double-blind, placebo-controlled, crossover trial designed to provide controlled clinical evidence in this population. Participants will take part in two separate 4-week periods of supplementation: one with the probiotic and one with a placebo. These periods are separated by a 4-week washout phase to avoid carryover effects. The probiotic or placebo will be taken once daily as capsules with water, with instructions to maintain consistent timing and to manage missed doses. Participants will be asked to keep their usual diet, exercise, and lifestyle habits during the study and avoid other probiotic or prebiotic supplements. Throughout the study, gastrointestinal symptoms will be assessed using validated questionnaires, focusing on constipation scores from the Gastrointestinal Symptom Rating Scale (GSRS). Additional outcomes include other gastrointestinal symptoms and markers of gut comfort. Safety monitoring includes self-reported adverse events collected at each testing visit and weekly check-ins. Total participation lasts about 13 to 14 weeks, including screening and testing visits, which may be in person or virtual.
CONDITIONS
Brief Title
Impact of Weizmannia (Bacillus) Coagulans JBI-YZ6.3 on Gut Health and Fecal Microbiome Changes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18 to 50 years
- Average daily bloating score over 5 on a specific questionnaire or bloating for more than 5 days in the past 14 days
- Body mass index (BMI) between 18.5 and 29.9 kg/m2, or BMI over 29.9 with less than 25% body fat for men and less than 30% for women
- Weight stable for the past 3 months (less than 5% variation)
- Healthy based on health history questionnaire
- Willing to maintain usual diet and report any changes, especially regarding probiotic or fermented foods
- Agree to avoid alcohol, caffeine, and strenuous exercise for 24 hours before test days
- Minimum physical activity of at least 30 minutes of moderate exercise at least 4 days per week for the past 3 months
- Able and willing to comply with study protocol
- Not currently enrolled in another clinical trial involving an investigational agent
- Provided voluntary written informed consent
You will not qualify if you...
- History or current treatment for heart or cardiovascular disease
- Kidney disease or regular dialysis
- Liver disease or clinically diagnosed liver impairment
- Diagnosed Type I or Type II diabetes
- Thyroid disease
- Major affective or psychiatric disorder requiring hospitalization in the past year
- Immune disorders such as HIV/AIDS
- History of cancer except localized skin or certain cervical cancers within 5 years
- Gastrointestinal abnormalities preventing swallowing or digestion (like dysphagia, malabsorption, inflammatory bowel disease)
- Recent treatment for gastrointestinal disorders within 30 days
- Neurological conditions
- Endocrinological disorders or hormone replacement therapy
- Hormone-related conditions in women (e.g., endometriosis, fibroids, polycystic ovary syndrome)
- Recent initiation or dosage change of statin or hypertension medications within 6 months
- Current antibiotic or medications affecting study outcomes
- Known allergies to study products
- Recent blood donation within 60 days
- Current or recent smoking or nicotine use
- Planned major lifestyle changes during the study
- Competitive athletes
- Recent history of alcohol or substance abuse
- Current use of anabolic steroids
- Recent use of investigational products within 30 days
- Recent use of probiotics or digestive supplements within 30 days
- Recent significant exercise training or weight loss
- Recent ketogenic or low carbohydrate diet
- Women who are pregnant, planning pregnancy, or breastfeeding currently or within 6 months
- Any condition judged by investigators to compromise safety or study quality
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (online)
Duration - 4 weeks per supplementation period, with a 4-week washout period in between
Participants will take a daily capsule of either Weizmannia (Bacillus) coagulans JBI-YZ6.3 or placebo for 4 weeks, followed by a 4-week washout period, then switch to the other treatment for another 4 weeks. They will maintain their usual diet and lifestyle during this time.
2 visits per supplementation period (at start and end), weekly check-ins during supplementation
Trial Site Locations
Total: 1 location
1
Lindenwood University
Saint Charles, Missouri, United States, 63301
Actively Recruiting
Research Team
A
Anthony M Hagele, MS
J
Joesi M Krieger, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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