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

Part of paid clinical trials in Saint Charles, Missouri.

Sponsor
Lindenwood University
Study ID
NCT07388264
Status
Recruiting
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Conditions

  • Constipation
  • Gastrointestinal Function
  • Gastrointestinal Symptoms
  • Gut Health

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Weizmannia (Bacillus) coagulans JBI-YZ6.3 — DIETARY_SUPPLEMENT
    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.
  • Placebo — DIETARY_SUPPLEMENT
    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

Study Details

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.

Key Dates

Start date
Jun 15, 2025
Status verified
Jan 2026
Primary completion
Jun 15, 2026
Completion
Jun 15, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Weizmannia (Bacillus) coagulans JBI-YZ6.3
  • Placebo Comparator: Placebo

Primary Outcome Measure

Constipation Score (Gastrointestinal Symptom Rating Scale) [ Time Frame: Baseline and end of each 4-week supplementation period (Weeks 0 and 4 of each intervention period) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lindenwood UniversitySaint CharlesMissouri63301
Anthony M Hagele, MS
[email protected]
6369494785
Joesi M Krieger, MS
[email protected]
6369494785
Chad M Kerksick, PhD (PRINCIPAL_INVESTIGATOR)

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Lindenwood University· Saint Charles, MO

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