NCT07388264

Impact of Weizmannia (Bacillus) Coagulans JBI-YZ6.3 on Gut Health and Fecal Microbiome Changes

Examining the Impact of Weizmannia (Bacillus) Coagulans JBI-YZ6.3 on Gut Health and Fecal Microbiome Changes

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Lindenwood University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is designed to examine the effects of supplementation with Weizmannia (Bacillus) coagulans JBI-YZ6.3 on gastrointestinal health in healthy, physically active adults. Probiotic supplementation has been shown to influence gastrointestinal symptoms, intestinal barrier function, and microbial composition, but responses vary depending on strain, dose, and population. Weizmannia (Bacillus) coagulans JBI-YZ6.3 is a spore-forming probiotic strain that is highly stable and may survive gastric transit, allowing for potential effects on gut function and symptom perception. However, controlled clinical data in physically active adults are limited. This study will employ a randomized, double-blind, placebo-controlled, crossover design to compare the effects of JBI-YZ6.3 with placebo. Approximately 30 healthy men and women aged 18 to 50 years will be recruited. All participants will be physically active and free of diagnosed gastrointestinal, metabolic, or inflammatory diseases. After completing an online screening visit, eligible participants will complete two 4-week supplementation periods. During one period, participants will consume a daily dose of Weizmannia (Bacillus) coagulans JBI-YZ6.3, and during the other period they will consume a matched placebo. The order of treatments will be randomized. A 4-week washout period will separate the two supplementation phases to minimize any potential carryover effects. Participants will attend laboratory or virtual testing visits at the start and end of each supplementation period (weeks 0 and 4 of each phase). Throughout the study, participants will be instructed to maintain their habitual diet, physical activity, and lifestyle behaviors, and to refrain from consuming additional probiotic or prebiotic supplements. Compliance with supplementation will be monitored by self-report and returned capsule counts. The primary outcome of this study is the constipation domain of the Gastrointestinal Symptom Rating Scale (GSRS), a validated questionnaire used to assess gastrointestinal symptom severity. Secondary outcomes will include additional GSRS domains and other self-reported measures of gastrointestinal comfort and function. Safety will be monitored throughout the study by collection of self-reported adverse events at each testing visit and via weekly check-ins during supplementation periods. This study will determine whether daily supplementation with Weizmannia (Bacillus) coagulans JBI-YZ6.3 improves constipation-related symptoms and overall gastrointestinal health in physically active adults compared with placebo.

Conditions

• Gastrointestinal Symptoms
• Constipation
• Gut Health
• Gastrointestinal Function

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Weizmannia (Bacillus) coagulans JBI-YZ6.3	Participants will ingest Weizmannia (Bacillus) coagulans JBI-YZ6.3 daily for 4 weeks. The supplement will be provided in capsule form and consumed once daily with approximately eight ounces of water. Participants will be instructed to consume the supplement at the same time each day. If a dose is missed, participants will be instructed to take the missed dose the following day by splitting the dose into one capsule in the morning and one capsule in the evening. Supplementation will occur during one of two 4-week intervention periods as part of a randomized, double-blind, placebo-controlled crossover design.
DIETARY_SUPPLEMENT	Placebo	Participants will ingest a placebo consisting of microcrystalline cellulose in capsule form for 4 weeks. The placebo capsules will be identical in size, color, and appearance to the active supplement. Participants will consume the placebo once daily with approximately eight ounces of water at the same time each day. If a dose is missed, participants will be instructed to take the missed dose the following day by splitting the dose into one capsule in the morning and one capsule in the evening. Placebo supplementation will occur during one of two 4-week intervention periods as part of a randomized, double-blind, placebo-controlled crossover design

Timeline

• Start date: 2025-06-15
• Primary completion: 2026-06-15
• Completion: 2026-06-15
• First posted: 2026-02-05
• Last updated: 2026-02-05

Locations

1 site across 1 country: United States