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

NCT07388264 | Recruiting

• 1 other identifier: IRB-25-41
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastrointestinal Symptoms; Constipation; Gut Health; Gastrointestinal Function

Outcome Measures

Primary Outcomes (1)

• Constipation Score (Gastrointestinal Symptom Rating Scale)

  Constipation will be assessed using the constipation domain of the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS is a validated 15-item questionnaire scored on a 7-point Likert scale, where higher scores indicate greater symptom severity. The constipation domain includes items related to hard stools, constipation, and sensation of incomplete bowel emptying. Scores will be compared between the Weizmannia (Bacillus) coagulans JBI-YZ6.3 and placebo conditions.

  Baseline and end of each 4-week supplementation period (Weeks 0 and 4 of each intervention period)

Secondary Outcomes (3)

• Total GSRS Score

  Baseline and end of each 4-week supplementation period

• GSRS Symptom Domain Scores

  Baseline and end of each 4-week supplementation period

• Stool Consistency (Bristol Stool Chart)

  Baseline, mid-intervention (Week 2 of each period), and end of each 4-week supplementation period

Other Outcomes (2)

• Resting Heart Rate

  Baseline, mid-intervention (Week 2 of each period), and end of each 4-week supplementation period

• Resting Blood Pressure

  Baseline, mid-intervention (Week 2 of each period), and end of each 4-week supplementation period

Study Arms (2)

Weizmannia (Bacillus) coagulans JBI-YZ6.3

EXPERIMENTAL

Dietary Supplement: Weizmannia (Bacillus) coagulans JBI-YZ6.3

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

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.

Weizmannia (Bacillus) coagulans JBI-YZ6.3

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

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Minimum baseline physical activity level (defined as at least 30 minutes of moderate intensity exercise at least 4 days per week for the past 3 months) Subject is willing and able to comply with the study protocol. Study participant is not currently enrolled in another clinical trial that involves the administration of some investigative agent Subject has given voluntary, written, informed consent to participate in the study.

You may not qualify if:

• Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea) Participant has been treated for a gastrointestinal related disorder, complication, or disorder within the past 30 days Positive medical history for any neurological condition or neurological disease Diagnosed with or being treated for any endocrinological disorder or currently used any form of hormone replacement (prescribed/doctor ordered or not) Women with a history of hormone-related conditions such as endometriosis, fibroids, polycystic ovary syndrome Currently prescribed for the first time statin drugs (i.e., Lipitor, Livalo, Crestor, Zocor, etc.) within the past 6 months or has had their dosage or medication changed within the past 6 months Currently prescribed for the first time hypertension medication (i.e., Beta-blockers, ACE Inhibitors, Alpha blockers, Vasodilators, etc.) within the past 6 months or has had their dosage or medication changed within the past 6 months Current antibiotic use or other prescription or over-the-counter medications that may impact study outcomes Have a known sensitivity or allergy to any of the study products Blood donation in past 60 days Current smoker (average of \> 1 pack per week within the past 3 months) or has quit within the past six months. This includes all forms of nicotine They plan major changes in lifestyle (i.e., diet, dieting, exercise level, travel, etc.) during the study Competitive athletes will be excluded History of alcohol or substance abuse in the 12 months prior to screening Current use of anabolic steroids (medically prescribed or otherwise) Receipt or use of an investigational product in another research study within 30 days of beginning the study protocol Report taking a probiotic or other dietary supplement know to impact digestion or gut function in the past 30 days Recent history (\<3 months) of exercise training or weight loss (\> 5%) Currently following a ketogenic or low carbohydrate diet within the past 30 days.
• Women who are pregnant, planning to become pregnant, or lactating currently or within the past six months Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data

Sponsors & Collaborators

• Lindenwood University: lead

Study Sites (1)

Lindenwood University

Saint Charles, Missouri, 63301, United States

RECRUITING

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chad M Kerksick, PhD

  Lindenwood University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony M Hagele, MS

CONTACT

6369494785; ahagele@lindenwood.edu

Joesi M Krieger, MS

CONTACT

6369494785; jmorey@lindenwood.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a randomized, double-blind, placebo-controlled, crossover design. All participants will receive both interventions in a randomized order. Each participant 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 to minimize potential carryover effects. Participants will be randomly assigned to one of two treatment sequences: probiotic followed by placebo, or placebo followed by probiotic. Randomization will be stratified by sex, age, and body mass index. Both participants and study personnel will remain blinded to treatment assignment for the duration of the study. All participants will serve as their own control, allowing within-subject comparisons of gastrointestinal symptoms, stool characteristics, and fecal microbiome outcomes between the probiotic and placebo conditions.

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 5, 2026
• Study Start: June 15, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)