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NCT07388264 · ClinicalTrials.gov registry record · NA
Impact of Weizmannia (Bacillus) Coagulans JBI-YZ6.3 on Gut Health and Fecal Microbiome Changes
A NA study of Constipation and Gut Health, sponsored by Lindenwood University.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT07388264: Recruiting NA study of Constipation and Gut Health, sponsored by Lindenwood University.
NCT07388264 is a NA study of Constipation and Gut Health that is actively recruiting participants, run by Lindenwood University. The registered enrollment target is 30 participants, below the 205-participant average among 54 other Constipation trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07388264, a NA study of Constipation and Gut Health, is actively recruiting participants, sponsored by Lindenwood University.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Weizmannia (Bacillus) coagulans JBI-YZ6.3
Study Locations (1)
Missouri
- Lindenwood University - Saint Charles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-06-15 |
| Est. Completion | 2026-06-15 |
| Phase | NA |
What NCT07388264 shows while recruiting
NCT07388264 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 205-participant average among 54 other Constipation trials with a reported enrollment target (85% lower).
The record links to 4 conditions, with Constipation appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07388264 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT07388264 about?
NCT07388264 is a clinical study titled "Impact of Weizmannia (Bacillus) Coagulans JBI-YZ6.3 on Gut Health and Fecal Microbiome Changes". 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 ga...
What is the current status of trial NCT07388264?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2025-06-15. Estimated completion is 2026-06-15.
What conditions does trial NCT07388264 study?
This clinical trial studies the following conditions: Constipation, Gut Health, Gastrointestinal Symptoms, Gastrointestinal Function.
What interventions are being tested in trial NCT07388264?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Weizmannia (Bacillus) coagulans JBI-YZ6.3 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT07388264?
This trial is sponsored by Lindenwood University, which has 29 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07388264 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07388264's enrollment target sits among peer trials
30 40th of 54 higher than 13 of 54 other Constipation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Constipation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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