Actively Recruiting
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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial 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. 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.
CONDITIONS
Official 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...
- Age between 18 and 50 years
- Average daily bloating score greater than 5 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 above 29.9 with body fat below 25% for men and below 30% for women
- Weight stable for the past 3 months with less than 5% variation
- Healthy based on health history questionnaire
- Willing to maintain existing diet and report any changes, especially related to probiotic or fermented foods
- Willing to avoid alcohol, caffeine, and strenuous exercise for 24 hours before each test day
- Minimum physical activity of 30 minutes moderate exercise at least 4 days per week for past 3 months
- Willing and able to comply with study protocol
- Not currently enrolled in another clinical trial involving an investigational agent
- Voluntarily provided written informed consent
You will not qualify if you...
- History or current treatment for heart or cardiovascular disease
- Treated for kidney disease, renal failure, or undergoing regular dialysis
- Liver disease or diagnosed hepatic impairment
- Diagnosed with Type I or II diabetes
- Diagnosed or treated for thyroid disease
- Major affective or psychiatric disorder requiring hospitalization within past year
- Diagnosed with immune disorders such as HIV/AIDS
- History of cancer except localized skin or in situ cervical cancer within 5 years
- Gastrointestinal abnormalities preventing swallowing or digestion
- Treated for gastrointestinal disorder within past 30 days
- History of neurological conditions
- Diagnosed or treated for endocrinological disorders or hormone replacement use
- Women with hormone-related conditions like endometriosis, fibroids, or polycystic ovary syndrome
- Started statin or hypertension medications within past 6 months or dosage changes within 6 months
- Current antibiotic use or medications affecting study outcomes
- Known allergies to study products
- Blood donation within past 60 days
- Current smoker or quit within past 6 months
- Planning major lifestyle changes during study
- Competitive athletes
- History of alcohol or substance abuse in past 12 months
- Current use of anabolic steroids
- Participation in other investigational studies within past 30 days
- Use of probiotics or digestive supplements within past 30 days
- Recent exercise training or weight loss over 5% in past 3 months
- Following ketogenic or low carbohydrate diet in past 30 days
- Pregnant, planning pregnancy, or lactating currently or within past 6 months
- Any condition that compromises safety or study data quality in investigator's opinion
AI-Screening
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Trial Site Locations
Total: 1 location
1
Lindenwood University
Saint Charles, Missouri, United States, 63301
Actively Recruiting
Research Team
A
Anthony M Hagele, MS
CONTACT
J
Joesi M Krieger, MS
CONTACT
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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