BloatingPhase 2NCT02950012
A Study to Evaluate OPTI-BIOME™ Bacillus Subtilis MB40 on Abdominal Discomfort, Gas and Bloating in a Healthy Population
A Phase 2 study testing OPTI-BIOME™ Bacillus subtilis MB40 in people with Bloating, run by BIO-CAT Microbials, LLC at 3 sites in 2 countries.
Trial summary
The purpose of this study is to investigate the effects of OPTI-BIOME™ (Bacillus subtilis MB40), a probiotic supplement, on bloating, gas and abdominal discomfort symptoms in otherwise healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Bloating
- What is being tested?
- OPTI-BIOME™ Bacillus subtilis MB40
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Oct 2016to Feb 2017
- Phase
- Phase 2
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female 18-75 years (inclusive) of age
- BMI 18.5-29.9 ±1 kg/m2
- Abdominal bloating intensity score ≥5 and at least two days of bloating over the 2 weeks prior to screening (assessed at screening by Abdominal Bloating questionnaire)
- Participants categorized as 'high bloaters' as defined by an average bloating score ≥ 5 during the run-in period assessed at baseline by question 3 of the Modified Daily Abdominal Discomfort, Gas, and Bloating Questionnaire, AND/OR, participants categorized as 'high frequency bloaters' as defined by greater than 7 days of high bloating (defined above) during the run-in period.
- For females, this should not include abdominal discomfort or bloating experienced during menstruation, if such symptoms occur due to menstrual cycle females should go through another run-in period.
- If female, participant is not of child bearing potential, which is defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation) OR
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- Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:
- Hormonal contraceptives (stable for 1 month) including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method
- Intrauterine devices
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner (shown successful as per appropriate follow-up)
- Healthy as determined by laboratory results, medical history, and physical exam
- Agrees to abstain from consuming unpasteurized bacteria-fermented foods including cheese and yogurt for 1 week prior to screening visit and throughout the study
- Agrees to abstain from using fiber supplements 2 weeks prior to screening and for the duration of the study
- Agrees to maintain current dietary habits and activity/training levels for two weeks prior to baseline and for the course of the study
- Agrees to avoid probiotics for one week prior to screening and for the course of the study
- Willingness to complete all the study requirements and attend all clinic visits.
- Has given voluntary, written, informed consent to participate in the study
Who cannot join
- Females who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- History of chronic inflammation or structural abnormality of the digestive tract (inflammatory bowel disease, duodenal or gastric ulcer, intestinal obstruction, or symptomatic cholelithiasis)
- Nocturnal and/or progressive abdominal pain (abdominal pain that increases in intensity and is consistent on regular basis)
- Significant weight loss over the past 3 months (significance to be determined by the Qualified Investigator)
- Type 1 and type 2 diabetes
- History of colorectal cancer, anal abscess, anal fistula, anal fissure, anal stenosis, gastric retention or obstruction, bowel resection, rectocele, or colostomy
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- Cancer except skin cancers completed excised with no chemotherapy or radiation following and with a negative follow up.
- Diagnosis of adenomatous polyposis, irritable bowel syndrome, chronic gastritis or functional dyspepsia, crohn disease, and celiac disease Renal or hepatic insufficiency
- Gastrointestinal bleeding or acute infection
- Immunodeficiency
- History of organ transplant
- Use of antibiotics within 4 weeks of randomization Routine (at least 3 times per week) consumption of probiotic or prebiotic supplements or supplemented foods and are unwilling to stop at least one week prior to screening and throughout the study
- Use of immunosuppressant drugs
- Change in anti-psychotic medication within 3 months of randomization
- Abdominal surgery within 6 months of randomization
- Plan to donate blood during the study or within 30 days of completing the study
- Participation in a clinical research trial within 30 days prior to randomization
- Allergy or sensitivity to study supplement or placebo ingredients
- Alcohol abuse (>2 standard alcoholic drinks per day) or drug abuse within the last 6 months
- Use of Medicinal Marijuana
- Cognitively impaired and/or unable to give informed consent
- Unstable medical conditions
- Clinically significant abnormal laboratory results at screening
- Any other condition which in the Qualified Investigator's opinion may adversely affect the volunteer's ability to complete the study or its measures or which may pose significant risk to the volunteer
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
KGK Clinical Trials Center
Foothill Ranch, California, 92610
KGK Clinical Trials Center
Orlando, Florida, 32806
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy and Safety of OPTI-BIOME™ Bacillus Subtilis MB40 on Abdominal Discomfort, Gas and Bloating in a Healthy Population
The purpose of this study is to investigate the effects of OPTI-BIOME™ (Bacillus subtilis MB40), a probiotic supplement, on bloating, gas and abdominal discomfort symptoms in otherwise healthy adults.
- Conditions
- Bloating
- Being tested
- OPTI-BIOME™ Bacillus subtilis MB40, Placebo
- Keywords
- Healthy, Bloating, Abdominal Discomfort, Gas, Probiotic, Bacillus Subtillis
- Medical subject headings
- Mucopolysaccharidosis IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPTI-BIOME™ Bacillus subtilis MB40Dietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| OPTI-BIOME™ Bacillus subtilis MB40 | Experimental | Not described Receives: Dietary Supplement: OPTI-BIOME™ Bacillus subtilis MB40 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly mean of the daily bloating scores
Discomfort, Gas and Bloating questionnaire
Measured: 4 weeks
Secondary outcomes (6)
Weekly mean of the daily gas score (flatulence)
Discomfort, Gas and Bloating questionnaire
Measured: 4 weeks
Weekly mean of the abdominal pain score
Discomfort, Gas and Bloating questionnaire
Measured: 4 weeks
Modified Gastrointestinal Symptom Rating Scale (GSRS) score
Measured: 4 weeks
Weekly mean stool consistency scores
Bristol stool scale
Measured: 4 weeks
Weekly mean number of bowel movements
Daily Bowel Habits Diary
Measured: 4 weeks
Quality of Life
Rand SF-36
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 posted31 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionFeb 2017
- Study completionFeb 2017
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 BloatingStudies 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- BIO-CAT Microbials, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- Tetyana Pelipyagina, MD', Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950012
- Sponsor's protocol ID
- 16OBHB
- Status last verified
- Oct 2021
- First submitted
- 28 Oct 2016
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Penet C, Kramer R, Little R, Spears JL, Parker J, Iyer JK, Guthrie N, Evans M. A Randomized, Double-blind, Placebo-controlled, Parallel Study Evaluating the Efficacy of Bacillus subtilis MB40 to Reduce Abdominal Discomfort, Gas, and Bloating. Altern Ther Health Med. 2021 Jun;27(S1):146-157.
PubMed 31719214
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy and Safety of OPTI-BIOME™ Bacillus Subtilis MB40 on Abdominal Discomfort, Gas and Bloating in a Healthy Population
- ClinicalTrials.gov ID
- NCT02950012
- Acronym / sponsor ID
- 16OBHB
- Conditions
- Bloating
- Keywords
- Healthy, Bloating, Abdominal Discomfort, Gas, Probiotic, Bacillus Subtillis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- BIO-CAT Microbials, LLCIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- Oct 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 31 Oct 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 effects of OPTI-BIOME™ (Bacillus subtilis MB40), a probiotic supplement, on bloating, gas and abdominal discomfort symptoms in otherwise 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
| Arm | Type | Receives |
|---|---|---|
| OPTI-BIOME™ Bacillus subtilis MB40 | Experimental | Dietary Supplement: OPTI-BIOME™ Bacillus subtilis MB40 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Male or female 18-75 years (inclusive) of age
- BMI 18.5-29.9 ±1 kg/m2
- Abdominal bloating intensity score ≥5 and at least two days of bloating over the 2 weeks prior to screening (assessed at screening by Abdominal Bloating questionnaire)
- Participants categorized as 'high bloaters' as defined by an average bloating score ≥ 5 during the run-in period assessed at baseline by question 3 of the Modified Daily Abdominal Discomfort, Gas, and Bloating Questionnaire, AND/OR, participants categorized as 'high frequency bloaters' as defined by greater than 7 days of high bloating (defined above) during the run-in period.
- If female, participant is not of child bearing potential, which is defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation) OR
Key exclusion criteria (24 listed)
- Females who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- History of chronic inflammation or structural abnormality of the digestive tract (inflammatory bowel disease, duodenal or gastric ulcer, intestinal obstruction, or symptomatic cholelithiasis)
- Nocturnal and/or progressive abdominal pain (abdominal pain that increases in intensity and is consistent on regular basis)
- Significant weight loss over the past 3 months (significance to be determined by the Qualified Investigator)
- Type 1 and type 2 diabetes
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 |
|---|---|---|
| OPTI-BIOME™ Bacillus subtilis MB40 | Dietary supplement | OPTI-BIOME™ Bacillus subtilis MB40 |
| Placebo | Other | Placebo |
Primary outcome
Weekly mean of the daily bloating scores
Time frame: 4 weeks
Discomfort, Gas and Bloating questionnaire
6 secondary outcomes
Weekly mean of the daily gas score (flatulence)
Time frame: 4 weeks
Weekly mean of the abdominal pain score
Time frame: 4 weeks
Modified Gastrointestinal Symptom Rating Scale (GSRS) score
Time frame: 4 weeks
Weekly mean stool consistency scores
Time frame: 4 weeks
Weekly mean number of bowel movements
Time frame: 4 weeks
Quality of Life
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 29 Oct 2021.
- Derived from this study: PubMed 31719214Penet C, Kramer R, Little R, Spears JL, Parker J, Iyer JK, Guthrie N, Evans M. A Randomized, Double-blind, Placebo-controlled, Parallel Study Evaluating the Efficacy of Bacillus subtilis MB40 to Reduce Abdominal Discomfort, Gas, and Bloating. Altern Ther Health Med. 2021 Jun;27(S1):146-157.
- Individual participant dataSharing planned: No
Related trials for Bloating
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Recruiting
Effects of Wheat Flour Milling Method on Glycemic Response and Gastrointestinal Symptoms
Gastrointestinal Irritation, Nutrition, Healthy
Active, not recruiting
The Safety And Efficacy Of A Probiotic Intervention On Lactulose Hydrogen Breath Test-Positive Patients And Related Gastrointestinal Symptoms
Small Intestinal Bacterial Overgrowth, SIBO
Recruiting
A Clinical Trial to Investigate the Safety and Efficacy of Bloat on Postprandial Bloating and Its Effects Over Time in Healthy Women
Bloating, Gastrointestinal Symptoms
Recruiting
Multi-strain Probiotic Supplement for Digestive Comfort and Well-being in Healthy Women
Gastrointestinal Discomfort, Bloating
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.
Tetyana Pelipyagina, MD' principal investigator
KGK Science Inc.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OPTI-BIOME™ Bacillus subtilis MB40 in people with Bloating, run by BIO-CAT Microbials, LLC at 3 sites in 2 countries.
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 19 inclusion and 24 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 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Weekly mean of the daily bloating scores (time frame: 4 weeks). 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 NCT02950012, 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 29 Oct 2021.