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| Name | Class |
|---|---|
| Beijing Hospital | OTHER_GOV |
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A single centre, double-blind, placebo-controlled study to evaluate the effect of the consumption of Bacillus coagulans at a daily dose of 1 x 10⁹ CFU on bowel habits, intestinal microbiota and gastrointestinal symptoms in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | Bacillus coagulans |
|
| Placebo | Placebo Comparator | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bacillus coagulans GBI-30,6086 (BC GBI-30) | Dietary Supplement | 2g powder/sachet, consists of bacillus coagulans at a dose of 1x10^9 CFU, taken once daily before a meal. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stool frequency | Changes in stool frequency, defined as the number of stools per day. Participants will record their daily stool frequency in a Health Daily Diary. Comparisons will be made between the intervention group and the control group and between timepoints, specifically at each week during the 2-week run-in period and each week from Week 1 to Week 4. | 6 weeks period, from enrollment to the end of the study. |
| Stool consistency. | Changes in stool consistency will be assessed using the standard Bristol Stool Scale (BSS). Participants will record their daily stool consistency in a Health Daily Diary. Comparisons will be made between the intervention group and the control group and between timepoints. Specifically, at each week during the 2-week run-in period and each week from Week 1 to Week 4. | 6 weeks period, from enrollment to the end of the study. |
| Improvement of constipation rate | Constipation is defined as present if a participant has <4 stools/week and absent if 4 stools/week or more were noted. Analysis will be conducted using data on stool frequency collected by the participants in the Health Daily Diary. Comparisons will be made between groups and between timepoints. Specifically at each week during the 2-week run-in period and each week from Week 1 to Week 4. | 6 weeks period, from enrollment to the end of the study. |
| Improvement in the defection effort | Data on symptoms during defection will be collected from the Health Daily Diary and scored as: 0=normal stool habit, 1=defection with mild discomfort, 2= defection with discomfort and difficulty, or 3=defection with frequent abdominal pain or burning. Comparisons will be made between the intervention group and control group and between timepoints. Specifically, at each week during the 2-week run-in period and each week from Week 1 to Week 4. | 6 weeks period, from enrollment to the end of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the impact of the intervention on the quality of life | Changes in Quality of Life (QoL) will be assessed using the 36-Item Short Form Survey (SF-36) version 2. The questionnaire evaluates eight domains of a person's health-related quality of life. Scores for the different domains are converted to a 0-100 scale, where a lower score indicates worse QoL and a higher score reflects better outcome. |
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Inclusion Criteria:
1- Adults male or female aged 18-65 years old. 2- Generally healthy but with irregular bowel movements, including <4 stools/week or periodic (over 2/week) loose stools 2- Agreed not to take other probiotics or prebiotics products during the study period, unless specified by the investigator.
3- Subjects enrolled in the study voluntarily and signed the Consent Form.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gang Hu, MD | Beijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40707016 | Derived | Gang H, Wei J, McFarland LV, Zahra R, Saez ME, Blanco-Rojo R, Millette M. Impact of Heyndrickxia (Bacillus) coagulans GBI-30, 6086 (BC30) probiotic on gastrointestinal function in healthy adults: a randomised controlled trial. Benef Microbes. 2025 Jul 22;17(1):29-46. doi: 10.1163/18762891-bja00084. |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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A prospective, interventional, randomized, double-blind, parallel, placebo-controlled clinical study. Eligible subjects were randomized at a ratio of 1:1 to receive Bacillus coagulans or placebo once daily for 28 days.
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| Placebo | Dietary Supplement | 2g powder/sachet, consists of maltodextrin only, taken once daily before a meal. |
|
| Changes in intestinal microbiota | Assessment of changes in the diversity of the fecal microbiota and relative abundance after intervention. Comparisons will be made between groups and between timepoints. Specifically at specifically at baseline (Day 0), Day 14, and Week 28 (end of the study). | 4 weeks period, assessment at Day 0, Day 14 and Day28 |
| Improvement in digestive symptoms scores | Assessed by the Gastrointestinal Symptom Rates Scale (GSRS).The GSRS has 15 items rated on a seven-point Likert scale from no discomfort to very severe discomfort. These items are grouped into five domains: abdominal pain, reflux, diarrhea, indigestion, and constipation. Scores are the mean of items within each domain, with higher scores indicating more severe symptoms. The overall GSRS score is the average of the five domain scores. Comparisons will be made between the intervention and control groups and at days 0, 14, and 28. | 6 weeks; assessment at Day 0, Day 14 and Day 28 |
| Improvement in upper GI symptoms | The Severity Of Dyspepsia Assessment (SODA) tool evaluates four symptoms: dyspepsia, heartburn, reflux, and nausea. Each symptom is rated by frequency: 1 (none per week), 2 (once per week), 3 (1-2 times per week), 4 (3-4 times per week), and 5 (daily or more). A decrease in the score over time indicates an improvement in symptoms. Comparisons will be made between the intervention and control groups and at days 0, 14, and 28. | 6 weeks; assessment at Day 0, Day 14 and Day 28 |
| 6 weeks; assessment at Day 0, Day 14 and Day 28. |
| Safety assessment-Safety as measured by adverse events | Documentation of any adverse events to the study product by participants in their daily health diary. | from Day 0 to Day 28 |
| Safety assessment -liver function- Aspartate Aminotransferase (AST) | To assess changes in the Aspartate Aminotransferase blood levels (U/L). | Day 0 and Day 28 |
| Safety assessment- Liver profile-alanine aminotransferase (ALT) | To assess changes in Alanine Aminotransferase (ALT) blood levels (U/L). | Day 0 and Day 28 |
| Safety assessment- Liver profile- Bilirubin | To assess changes in blood bilirubin levels (µmol/L). | Day 0 and Day 28 |
| Safety assessment- Heart rate (vitals) | Heart rate (beats per minute) | Day 0, Day 14 and Day 28 |
| Safety assessment- Blood pressure (vitals) | blood pressure, both of systolic and diastolic (mm Hg) | Day 0, Day 14 and Day 28 |
| Safety assessment-ECG findings | Including heart rate (beats per minute), PR Interval (milliseconds), PQ Interval (milliseconds), RR Interval (milliseconds), QRS Interval (milliseconds), and QT Interval (milliseconds), will be recorded. | Day 0 |
| Safety assessment-urine analysis | To determine any changes in the routine urine analysis test. | Day 0 and Day 28 |
| Safety assessment-stool analysis | To determine any changes in the routine stool analysis test. | Day 0 and Day 28 |
| Safety assessment- Chest X-ray findings | Standard Chest X-ray to be checked before the start of the study. | Day 0 |
| Safety assessment- Kidney profile-Urea | To assess changes in blood urea levels (mmol/L). | Day 0 and Day 28 |
| Safety assessment- Kidney profile-Creatinine | To assess changes in blood creatinine levels (µmol/L) | Day 0 and Day 28 |
| Safety assessment- Lipid Profile | To assess changes in blood lipid profile including : Cholesterol (mmol/L), Triglyceride (mmol/L), HDL (mmol/L) and LDL (mmol/L). | Day 0 and Day 28 |
| Safety assessment- Blood Glucose levels | To assess changes in blood glucose levels (mmol/L) | Day 0 and Day 28 |