Digestive DiscomfortNCT06644001
Bacillus Coagulans Effect on Gastrointestinal Function in Healthy Adults.
A study testing Bacillus coagulans GBI-30,6086 (BC GBI-30) in people with Digestive Discomfort and Constipation, run by Kerry Group P.L.C at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Digestive Discomfort, Constipation, Microbiota
- What is being tested?
- Bacillus coagulans GBI-30,6086 (BC GBI-30)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 30 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Subjects aged \<18 or \> 65 years, pregnant or lactating women, and those who are susceptible to allergens or have food allergies.
- Subjects with cardiovascular, cerebrovascular, hepatic, renal, hematopoietic diseases or endocrine diseases, and or mental illness.
- Subjects with constipation symptoms caused by surgical operation within the past 30 days; subjects with acute GI track diseases in the past 30 days; subjects with constipation symptoms due to severe organ lesion (colon cancer, severe enteritis, intestinal obstruction, inflammatory bowel disease, etc.)
- Subjects who could not eat orally or take the study products as prescribed or cannot comply with the protocol.
- Subjects administered relevant products recently, which would affect the outcome of the study.
- Subjects who took probiotics or prebiotics products (including yogurt, beverages or foods containing probiotics) within the past month, which may affect the results of the study.
Show all 10Show fewer
- Subjects who suffered from gastrointestinal disease within the past month.
- Subjects who had taken antibiotics in the past month.
- Subjects who had not taken the test product as prescribed or took other supplements or drugs.
- Subjects with incomplete data or incomplete information, so that the efficacy could not be estimated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Heyndrickxia (Bacillus) Coagulans Probiotic on Gastrointestinal Function in Healthy Adults: A Randomized Controlled Trial
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.
- Conditions
- Digestive Discomfort, Constipation, Microbiota
- Being tested
- Bacillus coagulans GBI-30,6086 (BC GBI-30), Placebo
- Keywords
- GI microbiota, bowel habits, GI symptoms
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDietary supplement
2g powder/sachet, consists of maltodextrin only, taken once daily before a meal.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Bacillus coagulans Receives: Dietary Supplement: Bacillus coagulans GBI-30,6086 (BC GBI-30) |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks period, from enrollment to the end of the study.
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).
Measured: 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.
Measured: 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.
Measured: 6 weeks; assessment at Day 0, Day 14 and Day 28
Secondary outcomes (15)
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.
Measured: 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.
Measured: from Day 0 to Day 28
Safety assessment -liver function- Aspartate Aminotransferase (AST)
To assess changes in the Aspartate Aminotransferase blood levels (U/L).
Measured: Day 0 and Day 28
Safety assessment- Liver profile-alanine aminotransferase (ALT)
To assess changes in Alanine Aminotransferase (ALT) blood levels (U/L).
Measured: Day 0 and Day 28
Safety assessment- Liver profile- Bilirubin
To assess changes in blood bilirubin levels (µmol/L).
Measured: Day 0 and Day 28
Safety assessment- Heart rate (vitals)
Heart rate (beats per minute)
Measured: Day 0, Day 14 and Day 28
Safety assessment- Blood pressure (vitals)
blood pressure, both of systolic and diastolic (mm Hg)
Measured: 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.
Measured: Day 0
Safety assessment-urine analysis
To determine any changes in the routine urine analysis test.
Measured: Day 0 and Day 28
Safety assessment-stool analysis
To determine any changes in the routine stool analysis test.
Measured: Day 0 and Day 28
Safety assessment- Chest X-ray findings
Standard Chest X-ray to be checked before the start of the study.
Measured: Day 0
Safety assessment- Kidney profile-Urea
To assess changes in blood urea levels (mmol/L).
Measured: Day 0 and Day 28
Safety assessment- Kidney profile-Creatinine
To assess changes in blood creatinine levels (µmol/L)
Measured: 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).
Measured: Day 0 and Day 28
Safety assessment- Blood Glucose levels
To assess changes in blood glucose levels (mmol/L)
Measured: Day 0 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start1 Jul 2021
- Primary completion30 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Digestive DiscomfortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kerry Group P.L.C
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Hospital
- Responsible party
- Sponsor
- Investigators
- Gang Hu, MD, Principal investigator, Beijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644001
- Sponsor's protocol ID
- S23-1464685
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40707016
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Heyndrickxia (Bacillus) Coagulans Probiotic on Gastrointestinal Function in Healthy Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06644001
- Acronym / sponsor ID
- S23-1464685
- Conditions
- Digestive Discomfort, Constipation, Microbiota
- Keywords
- GI microbiota, bowel habits, GI symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Kerry Group P.L.CIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Hospital
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Bacillus coagulans GBI-30,6086 (BC GBI-30)Bacillus coagulans |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- Subjects aged \<18 or \> 65 years, pregnant or lactating women, and those who are susceptible to allergens or have food allergies.
- Subjects with cardiovascular, cerebrovascular, hepatic, renal, hematopoietic diseases or endocrine diseases, and or mental illness.
- Subjects with constipation symptoms caused by surgical operation within the past 30 days; subjects with acute GI track diseases in the past 30 days; subjects with constipation symptoms due to severe organ lesion (colon cancer, severe enteritis, intestinal obstruction, inflammatory bowel disease, etc.)
- Subjects who could not eat orally or take the study products as prescribed or cannot comply with the protocol.
- Subjects administered relevant products recently, which would affect the outcome of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacillus coagulans GBI-30,6086 (BC GBI-30)2g powder/sachet, consists of bacillus coagulans at a dose of 1x10^9 CFU, taken once daily before a meal. | Dietary supplement | Probiotic |
| Placebo2g powder/sachet, consists of maltodextrin only, taken once daily before a meal. | Dietary supplement | Placebo |
Primary outcome
Stool frequency
Time frame: 6 weeks period, from enrollment to the end of the study.
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.
Stool consistency.
Time frame: 6 weeks period, from enrollment to the end of the study.
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.
Improvement of constipation rate
Time frame: 6 weeks period, from enrollment to the end of the study.
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.
Improvement in the defection effort
Time frame: 6 weeks period, from enrollment to the end of the study.
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.
Changes in intestinal microbiota
Time frame: 4 weeks period, assessment at Day 0, Day 14 and Day28
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).
Improvement in digestive symptoms scores
Time frame: 6 weeks; assessment at Day 0, Day 14 and Day 28
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.
Improvement in upper GI symptoms
Time frame: 6 weeks; assessment at Day 0, Day 14 and Day 28
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.
15 secondary outcomes
Assessment of the impact of the intervention on the quality of life
Time frame: 6 weeks; assessment at Day 0, Day 14 and Day 28.
Safety assessment-Safety as measured by adverse events
Time frame: from Day 0 to Day 28
Safety assessment -liver function- Aspartate Aminotransferase (AST)
Time frame: Day 0 and Day 28
Safety assessment- Liver profile-alanine aminotransferase (ALT)
Time frame: Day 0 and Day 28
Safety assessment- Liver profile- Bilirubin
Time frame: Day 0 and Day 28
Safety assessment- Heart rate (vitals)
Time frame: Day 0, Day 14 and Day 28
Safety assessment- Blood pressure (vitals)
Time frame: Day 0, Day 14 and Day 28
Safety assessment-ECG findings
Time frame: Day 0
Safety assessment-urine analysis
Time frame: Day 0 and Day 28
Safety assessment-stool analysis
Time frame: Day 0 and Day 28
Safety assessment- Chest X-ray findings
Time frame: Day 0
Safety assessment- Kidney profile-Urea
Time frame: Day 0 and Day 28
Safety assessment- Kidney profile-Creatinine
Time frame: Day 0 and Day 28
Safety assessment- Lipid Profile
Time frame: Day 0 and Day 28
Safety assessment- Blood Glucose levels
Time frame: Day 0 and Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Derived from this study: PubMed 40707016Gang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gang Hu, MD principal investigator
Beijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bacillus coagulans GBI-30,6086 (BC GBI-30) in people with Digestive Discomfort and Constipation, run by Kerry Group P.L.C at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool frequency (time frame: 6 weeks period, from enrollment to the end of the study.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06644001, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.