Healthy VolunteersNCT02872688
Influence of GanedenBC30 (Bacillus Coagulans GBI-30, 6086) on the Gut Microbiome in Healthy Adults
A study testing GanedenBC30 in people with Healthy Volunteers, run by Nutrasource Pharmaceutical and Nutraceutical Services, Inc. at 1 site in Canada.
Trial summary
The purpose of this study is to investigate the effect of a GanedenBC30, a probiotic bacteria (Bacillus coagulans strain GBI-30, 6086), on the gut microbiome in healthy adults. Subjects will complete a 2-week run-in period prior to receiving GanedenBC30. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- GanedenBC30
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2016to 13 Apr 2017
- 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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoker, or ex-smoker ≥6 months
- Body mass index 18.5- 34.9 kg/m2 (inclusive)
- Female subjects of childbearing potential [i.e. not surgically sterilized or post-menopausal (greater than one year since last menses)] must have negative urine pregnancy test and must be using an effective birth control method
- Willing to avoid alcohol consumption for 24 h prior to every clinic visit
- Willing to maintain their regimens of dietary supplements known to alter GI function (including, but not limited to, iron supplements and calcium)
- Willing to maintain a stable body weight, activity level and dietary pattern except for use of the study products, as directed
- Willing and able to provide informed written consent
Who cannot join
- Pregnancy or lactation, or subject unwilling to take appropriate contraceptives for the duration of the study
- Use of prescription drugs (other than birth control) within 1 month prior to visit 1b
- Use of any weight-loss programs or weight-loss medications (prescription or over-the counter) including, but not limited to, lipase inhibitors, within 3 months prior to visit 1b
- Use of over-the-counter or prescription laxatives or stool softeners within 1 month prior to visit 1b
- Use of antibiotics (other than topical) within 2 months prior to visit 1b
- Use of prebiotic supplements (e.g. fructans and galacto-oligosaccharides (GOS), psyllium, fiber, inulin) or probiotic supplements (i.e. live microorganisms) within 1 month of visit 1b or consumption of any yogurts or foods with added prebiotics or added probiotics within 2 weeks of visit 1b
Show all 22Show fewer
- History of blood clotting disorders or use of coagulation-inhibiting drugs (e.g. warfarin)
- Individuals with achlorhydria
- Presence of any disease (including, but not limited to: diabetes, gastrointestinal disease, cardiovascular disease, pancreatic, renal, or liver disease, chronic diarrhea or constipation, irritable bowel syndrome, or inflammatory bowel disease
- Abdominal or gastrointestinal surgery within the previous 12 months or planned abdominal or gastrointestinal surgery in the next 4 months
- Recent gastrointestinal food-borne illness (within 1 month prior to visit 1b)
- History of neurological disease (e.g. Parkinson's disease, stroke, traumatic brain injury, etc.)
- History of cancer (excluding non-melanoma skin cancer and basal cell carcinoma) in the past 5 years
- Controlled or uncontrolled hypertension defined as a seated resting systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg
- Abnormal laboratory test results of clinical significance, including, but not limited to ALT or AST ≥1.5X the upper limit of normal at screening
- Presence or history (past 6 months) of alcohol or drug abuse; alcohol use of >2 standard alcoholic drinks per day
- Extreme dietary habits (e.g. vegan or very low carbohydrate diets)
- Subject has a known allergy or intolerance to soy
- Allergy or intolerance to or contraindication to both of the rescue antibiotic regimens (Ciprofloxacin and Septra (contains Trimethoprim)
- Subject is unwilling or unable to abide by the requirements of the protocol
- Any condition that would interfere with the subject's ability to comply with study instructions, might confound the interpretation of the study, or put the subject at risk
- Subject has taken an investigational health product or has participated in a research study within 30 days prior to first study visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Baseline Controlled, Open Label, Single-arm Study to Investigate the Influence of GanedenBC30 (Bacillus Coagulans GBI-30, 6086) on the Gut Microbiome in Healthy Adults
The purpose of this study is to investigate the effect of a GanedenBC30, a probiotic bacteria (Bacillus coagulans strain GBI-30, 6086), on the gut microbiome in healthy adults. Subjects will complete a 2-week run-in period prior to receiving GanedenBC30. The study is open-label and subjects will act as their own controls as the microbiome is unique to individuals. During the run-in period, subjects will collect two stool samples and complete daily bowel habit diaries in order to understand usual habits and profile the microbiome for each subject. 30 subjects will take part in this research study conducted at Nutrasource Diagnostics Inc. Subjects will take GanedenBC30 for four weeks. Stool samples will be collected at the end of the study and daily bowel habit diaries maintained for the duration of the study.
- Conditions
- Healthy Volunteers
- Being tested
- GanedenBC30
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GanedenBC30Other
Also called Bacillus coagulans GBI-30, 6086
| Study group | Role | What they receive |
|---|---|---|
| GanedenBC30 | Experimental | Not described Receives: Other: GanedenBC30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the gut microbiome
Observe changes in the gut microbiome after 4 weeks of supplementation with GanedenBC30 as assessed by 16s RNA sequencing of feces
Measured: 4 weeks
Secondary outcomes (6)
Change in stool frequency
Measured: 4 weeks
Change in stool consistency
Calculated using the Bristol stool scale form rating each bowel movement and averaging over each week
Measured: 4 weeks
Changes severity of bloating as assessed by daily scores using a 4 point Likert scale
Determined using a 4 point Likert scale
Measured: 4 weeks
Changes severity of gas as assessed by daily scores using a 4 point Likert scale
Measured: 4 weeks
Changes severity of abdominal pain as assessed by daily scores using a 4 point Likert scale
Measured: 4 weeks
Changes in feeling of overall well-being as assessed by daily scores using a 5 point Likert scale
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startAug 2016
- Primary completion19 Dec 2016
- Study completion13 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Sponsor type
- Research network
- Collaborators
- Ganeden Biotech, Inc.
- Responsible party
- Sponsor
- Investigators
- Anthony Bier, MD, Principal investigator, Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872688
- Sponsor's protocol ID
- GANERPD-160001-RPD01
- Status last verified
- Sep 2017
- First submitted
- 11 Aug 2016
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Baseline Controlled, Open Label, Single-arm Study to Investigate the Influence of GanedenBC30 (Bacillus Coagulans GBI-30, 6086) on the Gut Microbiome in Healthy Adults
- ClinicalTrials.gov ID
- NCT02872688
- Acronym / sponsor ID
- GANERPD-160001-RPD01
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.Research network
- Collaborators
- Ganeden Biotech, Inc.
- Study start
- Aug 2016
- Primary completion
- 19 Dec 2016 (actual)
- Study completion
- 13 Apr 2017 (actual)
- First posted
- 19 Aug 2016 (estimated)
- 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.
The purpose of this study is to investigate the effect of a GanedenBC30, a probiotic bacteria (Bacillus coagulans strain GBI-30, 6086), on the gut microbiome in healthy adults. Subjects will complete a 2-week run-in period prior to receiving GanedenBC30. The study is open-label and subjects will act as their own controls as the microbiome is unique to individuals. During the run-in period, subjects will collect two stool samples and complete daily bowel habit diaries in order to understand usual habits and profile the microbiome for each subject. 30 subjects will take part in this research study conducted at Nutrasource Diagnostics Inc. Subjects will take GanedenBC30 for four weeks. Stool samples will be collected at the end of the study and daily bowel habit diaries maintained for the duration of the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GanedenBC30 | Experimental | Other: GanedenBC30 |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Non-smoker, or ex-smoker ≥6 months
- Body mass index 18.5- 34.9 kg/m2 (inclusive)
- Female subjects of childbearing potential [i.e. not surgically sterilized or post-menopausal (greater than one year since last menses)] must have negative urine pregnancy test and must be using an effective birth control method
- Willing to avoid alcohol consumption for 24 h prior to every clinic visit
- Willing to maintain their regimens of dietary supplements known to alter GI function (including, but not limited to, iron supplements and calcium)
Key exclusion criteria (22 listed)
- Pregnancy or lactation, or subject unwilling to take appropriate contraceptives for the duration of the study
- Use of prescription drugs (other than birth control) within 1 month prior to visit 1b
- Use of any weight-loss programs or weight-loss medications (prescription or over-the counter) including, but not limited to, lipase inhibitors, within 3 months prior to visit 1b
- Use of over-the-counter or prescription laxatives or stool softeners within 1 month prior to visit 1b
- Use of antibiotics (other than topical) within 2 months prior to visit 1b
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 |
|---|---|---|
| GanedenBC30Also: Bacillus coagulans GBI-30, 6086 | Other | GanedenBC30 |
Primary outcome
Changes in the gut microbiome
Time frame: 4 weeks
Observe changes in the gut microbiome after 4 weeks of supplementation with GanedenBC30 as assessed by 16s RNA sequencing of feces
6 secondary outcomes
Change in stool frequency
Time frame: 4 weeks
Change in stool consistency
Time frame: 4 weeks
Changes severity of bloating as assessed by daily scores using a 4 point Likert scale
Time frame: 4 weeks
Changes severity of gas as assessed by daily scores using a 4 point Likert scale
Time frame: 4 weeks
Changes severity of abdominal pain as assessed by daily scores using a 4 point Likert scale
Time frame: 4 weeks
Changes in feeling of overall well-being as assessed by daily scores using a 5 point Likert scale
Time frame: 4 weeks
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 13 Sep 2017.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Anthony Bier, MD principal investigator
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GanedenBC30 in people with Healthy Volunteers, run by Nutrasource Pharmaceutical and Nutraceutical Services, Inc. at 1 site in Canada.
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 7 inclusion and 22 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 13 Sep 2017. 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 Canada. 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. 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?
Changes in the gut microbiome (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2017.