Stool FrequencyNCT05123664
A Prospective, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy of Bacillus Coagulans Unique IS2 on Improving Bowel Movement Characteristics, Gastrointestinal-related Symptoms and Quality of Life in Healthy Adult Participants
A study testing Capsule in people with Stool Frequency, run by PepsiCo Global R&D at 1 site in Canada.
Trial summary
This prospective, randomized, placebo-controlled, double-blind study will be conducted to assess the efficacy of 2 billion CFU/day of B. coagulans Unique IS2 on improving bowel movement characteristics, gastrointestinal-related symptoms and quality of life in healthy adult participants who are experiencing more than… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stool Frequency
- What is being tested?
- Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 1 siteCanada
- Study dates
- 11 Apr 2022to 20 Dec 2023
- 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
- Healthy male and female adult participants who are 18 to 65 years of age (inclusive).
- In good general health and good oral health (no active or uncontrolled diseases or conditions).
- Have a body mass index (BMI) between 18.5 to 34.9 kg/m2 (inclusive).
- Have normal (or acceptable to the investigator) vital signs (blood pressure and heart rate) at screening (Visit 1) and baseline (Visit 2) and normal (or acceptable to the investigator) physical exam findings (if applicable) at screening.
- Individuals of childbearing potential must agree to practice a medically acceptable form of birth control for a defined timeframe prior to the start of run-in and throughout the study to avoid pregnancy, including:
- use for at least 3 months prior to run-in: hormonal contraceptives including oral contraceptives, hormone birth control patch (e.g., Ortho Evra), vaginal contraceptive ring (e.g., NuvaRing), injectable contraceptives (e.g., Depo-Provera, Lunelle), hormone implant (e.g., Norplant System), or intrauterine devices (e.g., Mirena); or
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- use for at least 1 month prior to run-in: double-barrier method (e.g., condom with diaphragm or condom with cervical cap), non-hormonal intrauterine devices (i.e., copper), or complete abstinence from sexual intercourse that can result in pregnancy; or
- vasectomy of partner at least 6 months prior to run-in. Individuals with the potential to impregnate others must agree to avoid pregnancy by using the double-barrier method mentioned above or complete abstinence from sexual intercourse that can result in pregnancy.
- Agree to refrain from treatments in the defined timeframes as outlined in Section 6.5.
- Agree not to change current dietary habits (with the exception of avoiding pro- and prebiotic supplements), smoking and alcohol consumption habits, and activity/training levels starting from the beginning of the run-in period and for the duration of the study.
- Agree to avoid anal penetration for 72 hours prior to fecal sample collection.
- Agree to not receive a vaccine for COVID-19 throughout the duration of the study.
- Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.
- At Visit 2/baseline, based on study diary data, an average of ≥3.0 and <7.0 weekly SBM (occurring without use of laxatives/suppositories/enema/manual maneuvers to defecate on the day of bowel movements or the day before) during the run-in period.
- At Visit 2/baseline, achieve a study product compliance of 80-120% (inclusive) for the run-in period.
Who cannot join
- Participants who are lactating, pregnant or planning to become pregnant during the study.
- Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients, or not able to take any of the rescue medications.
- Received a vaccine for COVID-19 in the last 2 weeks prior to screening, current COVID-19 infections, or COVID-19 long haulers (those who were first infected with COVID-19 ≥28 days prior to screening and continue to have symptoms).
- Current diagnosis or history of irritable bowel syndrome (IBS), constipation (defined as an average of <3 defecations weekly for ≥3 months), inflammatory bowel disease (IBD, including ulcerative colitis and Crohn's disease), functional constipation or diarrhea (defined by the Rome IV diagnostic criteria), celiac disease, lactose intolerance and/or malabsorption, gastroparesis, gastroenteritis within the past 60 days, endometriosis, diverticulosis, gastric or duodenal ulcers, pancreatitis, or eating disorder; history of intestinal surgery (excluding appendectomy or herniorrhaphy), or history of bariatric surgery.
- Constipation (defined as <3 defecations on average per week), and/or diarrhea (defined as ≥3 loose or liquid stools/day on any day) during run-in (based on daily diary at Visit 2/baseline).
- Use of concomitant treatments within the defined timeframes as outlined in Section 6.5.
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- Change of dietary habits (e.g., starting a FODMAP diet, ketogenic diet or fiber supplement use, major increase or major decrease in consumption of high-fiber foods, etc.) within the 4 weeks prior to the beginning of the run-in period.
- Having a history of heart disease, uncontrolled high blood pressure (≥140 systolic or ≥90 diastolic mmHg), renal or hepatic impairment/disease, uncontrolled diabetes (Type I or Type II), bipolar disorder, hepatic or renal dysfunction, unstable thyroid disease, immune disorders and/or immunocompromised (e.g. HIV/AIDS), a history of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit), or a history of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential subject at risk because of participation in the study, or influence the results or the potential participant's ability to participate in the study.
- Major surgery in 3 months prior to screening or planned major surgery during the course of the study.
- History of alcohol or substance abuse, as deemed by the investigator, in the 12 months prior to screening.
- Receipt or use of test product(s) in another research study within 30 days prior to run-in or longer if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study.
- Any other active or unstable medical conditions or use of medications/supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: Nutrasource Clinical Trial Site
Guelph, Ontario, N1G 0B4
About this study
This prospective, randomized, placebo-controlled, double-blind study will be conducted to assess the efficacy of 2 billion CFU/day of B. coagulans Unique IS2 on improving bowel movement characteristics, gastrointestinal-related symptoms and quality of life in healthy adult participants who are experiencing more than 3.0 but less than 6.0 complete spontaneous bowel movements (CSBM) per week on average.
Following a run-in period of 14 days to assess participants' baseline bowel habits, they are randomized to either B. coagulans or placebo for one month. The primary endpoint is change from baseline at 4 weeks in stool frequency in the test product group compared to the placebo group for average number of daily bowel movements over the week prior to the study visits. Secondary endpoints are stool frequency at weeks 1, 2, 3, stool quality measured by Bristol stool type scores, and gastrointestinal quality of life index (GIQLI) scores and subcategories (social, physical, emotional, symptoms).
- Conditions
- Stool Frequency
- Being tested
- Capsule
- Keywords
- B. coagulans, probiotic, Bristol stool chart, GIQLI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsuleOther
1 cap daily at same time of the day with or without food for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Bacillus coagulans | Experimental | 2 billion CFU Bacillus coagulans Unique IS2 per capsule Receives: Other: Capsule |
| Placebo | Placebo comparator | Appearance-matched capsule Receives: Other: Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool frequency
Number of daily bowel movements
Measured: Change from 7 day average prior to baseline versus 7 day average in fourth week. A significant increase is desirable.
Secondary outcomes (3)
Stool frequency
Number of daily bowel movements
Measured: Change from 7 day average prior to baseline to week 1, week 2 and week 3 averages. An increase from baseline stool frequency at Weeks 1, 2, or 3 in the B coagulans group, which is significantly better than the change in the placebo group, is desirable.
Stool quality
Bristol stool chart scale rated Type 1 (separate hard lumps) to Type 7 (watery, no solid pieces)
Measured: Change from 7 day average prior to baseline to week 1, 2, 3 and 4 average scores. An increase from baseline stool frequency in the B. coagulans group at weeks 1,2,3,4 which is significantly better than the change in the placebo group, is desirable.
Gastrointestinal quality of life index
Gastrointestinal quality of life index (GIQLI) total scores based on subcategory scores (social, physical, emotional, symptoms). 36 items are each rated from 0 (all the time) to 4 (never)
Measured: Change from baseline score to week 4 score. An improved score is desirable.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start11 Apr 2022
- Primary completion20 Dec 2023
- Study completion20 Dec 2023
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 Stool FrequencyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony Bier, MD, Principal investigator, Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123664
- Sponsor's protocol ID
- PEP-2006
- Status last verified
- Mar 2024
- First submitted
- 5 Nov 2021
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
LeMoire A, Replogle R, Shinn L, Kamil A, Lin L, Kuttenkeuler AP, Baisley J, Wang J, Girard SA, Recker S, Bier A. Bacillus coagulans Unique IS2 improves stool characteristics in healthy adults with infrequent bowel movements: a randomized, double-blind, placebo-controlled trial. Benef Microbes. 2025 Jun 1;16(5):533-543. doi: 10.1163/18762891-bja00072.
PubMed 40456531
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy of Bacillus Coagulans Unique IS2 on Improving Bowel Movement Characteristics, Gastrointestinal-related Symptoms and Quality of Life in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT05123664
- Acronym / sponsor ID
- PEP-2006
- Conditions
- Stool Frequency
- Keywords
- B. coagulans, probiotic, Bristol stool chart, GIQLI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 17 Nov 2021 (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.
This prospective, randomized, placebo-controlled, double-blind study will be conducted to assess the efficacy of 2 billion CFU/day of B. coagulans Unique IS2 on improving bowel movement characteristics, gastrointestinal-related symptoms and quality of life in healthy adult participants who are experiencing more than 3.0 but less than 6.0 complete spontaneous bowel movements (CSBM) per week on average.
Following a run-in period of 14 days to assess participants' baseline bowel habits, they are randomized to either B. coagulans or placebo for one month. The primary endpoint is change from baseline at 4 weeks in stool frequency in the test product group compared to the placebo group for average number of daily bowel movements over the week prior to the study visits. Secondary endpoints are stool frequency at weeks 1, 2, 3, stool quality measured by Bristol stool type scores, and gastrointestinal quality of life index (GIQLI) scores and subcategories (social, physical, emotional, symptoms).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bacillus coagulans | Experimental | Other: Capsule2 billion CFU Bacillus coagulans Unique IS2 per capsule |
| Placebo | Placebo comparator | Other: CapsuleAppearance-matched capsule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Healthy male and female adult participants who are 18 to 65 years of age (inclusive).
- In good general health and good oral health (no active or uncontrolled diseases or conditions).
- Have a body mass index (BMI) between 18.5 to 34.9 kg/m2 (inclusive).
- Have normal (or acceptable to the investigator) vital signs (blood pressure and heart rate) at screening (Visit 1) and baseline (Visit 2) and normal (or acceptable to the investigator) physical exam findings (if applicable) at screening.
- Individuals of childbearing potential must agree to practice a medically acceptable form of birth control for a defined timeframe prior to the start of run-in and throughout the study to avoid pregnancy, including:
Key exclusion criteria (12 listed)
- Participants who are lactating, pregnant or planning to become pregnant during the study.
- Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients, or not able to take any of the rescue medications.
- Received a vaccine for COVID-19 in the last 2 weeks prior to screening, current COVID-19 infections, or COVID-19 long haulers (those who were first infected with COVID-19 ≥28 days prior to screening and continue to have symptoms).
- Current diagnosis or history of irritable bowel syndrome (IBS), constipation (defined as an average of <3 defecations weekly for ≥3 months), inflammatory bowel disease (IBD, including ulcerative colitis and Crohn's disease), functional constipation or diarrhea (defined by the Rome IV diagnostic criteria), celiac disease, lactose intolerance and/or malabsorption, gastroparesis, gastroenteritis within the past 60 days, endometriosis, diverticulosis, gastric or duodenal ulcers, pancreatitis, or eating disorder; history of intestinal surgery (excluding appendectomy or herniorrhaphy), or history of bariatric surgery.
- Constipation (defined as <3 defecations on average per week), and/or diarrhea (defined as ≥3 loose or liquid stools/day on any day) during run-in (based on daily diary at Visit 2/baseline).
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 |
|---|---|---|
| Capsule1 cap daily at same time of the day with or without food for 4 weeks | Other | Bacillus coagulans, Placebo |
Primary outcome
Stool frequency
Time frame: Change from 7 day average prior to baseline versus 7 day average in fourth week. A significant increase is desirable.
Number of daily bowel movements
3 secondary outcomes
Stool frequency
Time frame: Change from 7 day average prior to baseline to week 1, week 2 and week 3 averages. An increase from baseline stool frequency at Weeks 1, 2, or 3 in the B coagulans group, which is significantly better than the change in the placebo group, is desirable.
Stool quality
Time frame: Change from 7 day average prior to baseline to week 1, 2, 3 and 4 average scores. An increase from baseline stool frequency in the B. coagulans group at weeks 1,2,3,4 which is significantly better than the change in the placebo group, is desirable.
Gastrointestinal quality of life index
Time frame: Change from baseline score to week 4 score. An improved score is desirable.
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 6 Mar 2024.
- Derived from this study: PubMed 40456531LeMoire A, Replogle R, Shinn L, Kamil A, Lin L, Kuttenkeuler AP, Baisley J, Wang J, Girard SA, Recker S, Bier A. Bacillus coagulans Unique IS2 improves stool characteristics in healthy adults with infrequent bowel movements: a randomized, double-blind, placebo-controlled trial. Benef Microbes. 2025 Jun 1;16(5):533-543. doi: 10.1163/18762891-bja00072.
- 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.
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 Capsule in people with Stool Frequency, run by PepsiCo Global R&D 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 15 inclusion and 12 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 6 Mar 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 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. 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: Change from 7 day average prior to baseline versus 7 day average in fourth week. A significant increase is desirable.). 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 NCT05123664, 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 6 Mar 2024.