Impact of Weizmannia (Bacillus) Coagulans JBI-YZ6.3 on Gut Health and Fecal Microbiome Changes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorLindenwood University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Crossover
Treatments tested in this trial
Weizmannia (Bacillus) coagulans JBI-YZ6.3
Dietary supplementParticipants 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 supplementParticipants 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
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Weizmannia (Bacillus) coagulans JBI-YZ6.3Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline and end of each 4-week supplementation period (Weeks 0 and 4 of each intervention period)Secondary outcomes
1
Total GSRS Score
Overall gastrointestinal symptom severity will be assessed using the total score of the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS includes 15 items rated on a 7-point Likert scale assessing gastrointestinal symptoms over the past week.
Time frame
Baseline and end of each 4-week supplementation period2
GSRS Symptom Domain Scores
Individual GSRS domain scores for diarrhea, indigestion, abdominal pain, and reflux will be calculated and compared between the probiotic and placebo conditions.
Time frame
Baseline and end of each 4-week supplementation period3
Stool Consistency (Bristol Stool Chart)
Stool consistency will be assessed using the Bristol Stool Chart, which classifies stool form into seven categories ranging from hard pellets to watery stool. Scores will be compared between supplementation conditions.
Time frame
Baseline, mid-intervention (Week 2 of each period), and end of each 4-week supplementation periodOther outcomes
1
Resting Heart Rate
Resting heart rate will be measured using an automated blood pressure monitor after five minutes of seated rest.
Time frame
Baseline, mid-intervention (Week 2 of each period), and end of each 4-week supplementation period2
Resting Blood Pressure
Resting blood pressure will be measured using an automated blood pressure monitor after five minutes of seated rest.
Time frame
Baseline, mid-intervention (Week 2 of each period), and end of each 4-week supplementation periodSponsors and contacts
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Source ClinicalTrials.gov