Functional BloatingNCT06308146
Effect of Bacillus Subtilis ATCC 122264 Supplementation on Gas Symptoms and Quality of Life in Participants With Functional Bloating
A study testing Bacillus subtilis ATCC 122264 in people with Functional Bloating, run by Kerry Group P.L.C at 1 site in Canada.
Trial summary
A randomized, double blind, placebo-controlled, 2-arm parallel study to evaluate the efficacy of Bacillus subtillis in providing relief and improving quality of life in participants suffering from functional abdominal bloating/distension when administered for a period of 8 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Bloating
- What is being tested?
- Bacillus subtilis ATCC 122264
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 21 Apr 2022to 11 Oct 2022
- 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 adult participants who are 18 to 65 years of age (inclusive).
- Have a body mass index (BMI) between 18.5 to 34.9 kg/m2 (inclusive).
- In good general health (no active or uncontrolled diseases or conditions).
- Participants with Functional Abdominal Bloating/Distension, defined by ROME IV criteria as below: Must meet both of the following diagnostic criteria fulfilled for the last three months with symptom onset ≥ 6 months prior to diagnosis: a) Recurrent bloating and/or distension occurring on average at least 1 day/week, and abdominal bloating and/or distension predominates over other symptoms (bloating-related mild pain may be present as well as minor bowel movement abnormalities). b) There are insufficient criteria for a diagnosis of irritable bowel syndrome, functional constipation, functional diarrhea, or post-prandial distress syndrome.
- Individuals of childbearing potential must have negative urine pregnancy result at baseline and agree to practice acceptable form of birth control for a certain period prior to the first dose of study product and throughout the study duration.
- Individuals with the potential to get others pregnant must agree to use condom or other acceptable methods to prevent pregnancy throughout the study. Complete abstinence from sexual intercourse that can result in pregnancy is also acceptable.
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- Be 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, carry out all study-related procedures, communicate effectively with the study staff, and agree to allow evaluations related to digestive health.
- Agree to refrain from treatments in the defined timeframe, as outlined in the protocol.
- Agree not to change current dietary habits known to alter GI function (including, but not limited to, iron supplements) within the 4 weeks prior to baseline visit or anytime during the study duration.
- Agree not to change smoking and alcohol consumption habits, and activity/training levels two weeks prior to baseline and for the duration of the study.
Who cannot join
- Individuals who are lactating, pregnant or planning to become pregnant during the study duration.
- Have a known sensitivity, intolerability, or allergy to wheat, soy or milk or any other ingredients of the study products or their excipients, or all of the rescue medications as outlined in the protocol.
- An unexplained weight loss of ≥5% of body weight in one month or ≥10% over a period of six months as assessed at screening.
- Received a vaccine for COVID-19 in the 2 weeks prior to screening or during the study period, current COVID-19 infections, or currently have the post COVID-19 condition as defined by World Health Organization (WHO) (i.e., individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis).
- Known medical history of organic disease including IBS, inflammatory bowel disease (IBD; including ulcerative colitis and Crohn's disease), functional constipation and diarrhea (defined by the Rome IV diagnostic criteria), celiac disease, gluten intolerance/sensitivity, a benign or malignant tumor of intestine or colon or significant systemic disease, self-reported lactose intolerance and/or malabsorption, gastroparesis, gastroenteritis, endometriosis, diverticulosis, gastric or duodenal ulcers, history of intestinal surgery (excluding appendectomy or herniorrhaphy), history of bariatric surgery, pancreatitis, or eating disorder.
- Major surgery in the past 3 months or individuals who have planned surgery during the course of the study, or participants who have had a colonoscopy in past 3 months.
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- Use of concomitant treatments within the defined timeframe, as outlined in the protocol.
- Change from current routine/ standard dietary habits (e.g., newly starting or modifying current restrictive diet such as FODMAP diet, ketogenic diet, vegan diet etc. or notable change in eating habits e.g., significant change in number of daily meals) within the 4 weeks prior to the baseline visit or anytime during the study duration.
- 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 participant at risk because of participation in the study, or influence the results or the potential participant's ability to participate in the study.
- History of alcohol or substance abuse in the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention program).
- Receipt or use of test product(s) in another research study within 30 days prior to the baseline visit.
- 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 or the quality of the study data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Efficacy of Bacillus Subtilis ATCC 122264 on Intestinal Gas Symptoms and Quality of Life in Participants With Functional Bloating: a Randomized, Double-blind, Placebo-controlled, 2-arm Parallel Study
A randomized, double blind, placebo-controlled, 2-arm parallel study to evaluate the efficacy of Bacillus subtillis in providing relief and improving quality of life in participants suffering from functional abdominal bloating/distension when administered for a period of 8 weeks.
- Conditions
- Functional Bloating
- Being tested
- Bacillus subtilis ATCC 122264, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacillus subtilis ATCC 122264Dietary supplement
One capsule (5 billion CFU) per day for 8 weeks.
PlaceboDietary supplement
One capsule per day for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic, Bacillus subtilis | Experimental | Bacillus subtilis ATCC 122264; One capsule per day with a larger meal; providing 5 billion CFU for 8 weeks. Receives: Dietary Supplement: Bacillus subtilis ATCC 122264 |
| Placebo | Placebo comparator | Placebo; matched the test product in colour, size, smell and texture and contained only the excipients (maltodextrin and hydroxypropylmethylcellulose); one capsule per day with a larger meal, for 8 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on intestinal gas symptoms and quality of life
to evaluate change from baseline in IGQ score at Week 8 between groups. The Intestinal Gas Questionnaire (IGQ) is a 17-item questionnaire that assesses the severity of six GI-related symptoms and their impact on the quality of life. The global score is between (0-100) with higher score means worst symptoms or impact.
Measured: 8 weeks
Secondary outcomes (1)
Effect on intestinal gas symptoms and quality of life
to evaluate change from baseline in IGQ score at Week 4 between groups The Intestinal Gas Questionnaire (IGQ) is a 17-item questionnaire that assesses the severity of six GI-related symptoms and their impact on the quality of life. The global score is between (0-100) with higher score means worst symptoms or impact.
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 posted13 Mar 2024
- Study start21 Apr 2022
- Primary completion11 Oct 2022
- Study completion11 Oct 2022
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 Functional 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either the probiotic or placebo. Study products (i.e., TP and placebo) will be dispensed by the site as per the randomization scheme at the study visits.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kerry Group P.L.C
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308146
- Sponsor's protocol ID
- S21-1249496
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
LeMoire A, Lin L, Girard SA, Baisley J, Wang J, Atif A, Zahra R, Millette M. Effect of Bacillus subtilis ATCC 122264 on intestinal gas symptoms and quality of life in adults with functional bloating. Benef Microbes. 2025 Jan 28;16(3):281-292. doi: 10.1163/18762891-bja00057.
PubMed 39929203
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Bacillus Subtilis ATCC 122264 on Intestinal Gas Symptoms and Quality of Life in Participants With Functional Bloating: a Randomized, Double-blind, Placebo-controlled, 2-arm Parallel Study
- ClinicalTrials.gov ID
- NCT06308146
- Acronym / sponsor ID
- S21-1249496
- Conditions
- Functional Bloating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kerry Group P.L.CIndustry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 11 Oct 2022 (actual)
- Study completion
- 11 Oct 2022 (actual)
- First posted
- 13 Mar 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 randomized, double blind, placebo-controlled, 2-arm parallel study to evaluate the efficacy of Bacillus subtillis in providing relief and improving quality of life in participants suffering from functional abdominal bloating/distension when administered for a period of 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either the probiotic or placebo. Study products (i.e., TP and placebo) will be dispensed by the site as per the randomization scheme at the study visits.
| Arm | Type | Receives |
|---|---|---|
| Probiotic, Bacillus subtilis | Experimental | Dietary Supplement: Bacillus subtilis ATCC 122264Bacillus subtilis ATCC 122264; One capsule per day with a larger meal; providing 5 billion CFU for 8 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo; matched the test product in colour, size, smell and texture and contained only the excipients (maltodextrin and hydroxypropylmethylcellulose); one capsule per day with a larger meal, for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy adult participants who are 18 to 65 years of age (inclusive).
- Have a body mass index (BMI) between 18.5 to 34.9 kg/m2 (inclusive).
- In good general health (no active or uncontrolled diseases or conditions).
- Participants with Functional Abdominal Bloating/Distension, defined by ROME IV criteria as below: Must meet both of the following diagnostic criteria fulfilled for the last three months with symptom onset ≥ 6 months prior to diagnosis: a) Recurrent bloating and/or distension occurring on average at least 1 day/week, and abdominal bloating and/or distension predominates over other symptoms (bloating-related mild pain may be present as well as minor bowel movement abnormalities). b) There are insufficient criteria for a diagnosis of irritable bowel syndrome, functional constipation, functional diarrhea, or post-prandial distress syndrome.
- Individuals of childbearing potential must have negative urine pregnancy result at baseline and agree to practice acceptable form of birth control for a certain period prior to the first dose of study product and throughout the study duration.
Key exclusion criteria (13 listed)
- Individuals who are lactating, pregnant or planning to become pregnant during the study duration.
- Have a known sensitivity, intolerability, or allergy to wheat, soy or milk or any other ingredients of the study products or their excipients, or all of the rescue medications as outlined in the protocol.
- An unexplained weight loss of ≥5% of body weight in one month or ≥10% over a period of six months as assessed at screening.
- Received a vaccine for COVID-19 in the 2 weeks prior to screening or during the study period, current COVID-19 infections, or currently have the post COVID-19 condition as defined by World Health Organization (WHO) (i.e., individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis).
- Known medical history of organic disease including IBS, inflammatory bowel disease (IBD; including ulcerative colitis and Crohn's disease), functional constipation and diarrhea (defined by the Rome IV diagnostic criteria), celiac disease, gluten intolerance/sensitivity, a benign or malignant tumor of intestine or colon or significant systemic disease, self-reported lactose intolerance and/or malabsorption, gastroparesis, gastroenteritis, endometriosis, diverticulosis, gastric or duodenal ulcers, history of intestinal surgery (excluding appendectomy or herniorrhaphy), history of bariatric surgery, pancreatitis, or eating disorder.
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 subtilis ATCC 122264One capsule (5 billion CFU) per day for 8 weeks. | Dietary supplement | Probiotic, Bacillus subtilis |
| PlaceboOne capsule per day for 8 weeks. | Dietary supplement | Placebo |
Primary outcome
Effect on intestinal gas symptoms and quality of life
Time frame: 8 weeks
to evaluate change from baseline in IGQ score at Week 8 between groups. The Intestinal Gas Questionnaire (IGQ) is a 17-item questionnaire that assesses the severity of six GI-related symptoms and their impact on the quality of life. The global score is between (0-100) with higher score means worst symptoms or impact.
1 secondary outcome
Effect on intestinal gas symptoms and 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 15 Mar 2024.
- Derived from this study: PubMed 39929203LeMoire A, Lin L, Girard SA, Baisley J, Wang J, Atif A, Zahra R, Millette M. Effect of Bacillus subtilis ATCC 122264 on intestinal gas symptoms and quality of life in adults with functional bloating. Benef Microbes. 2025 Jan 28;16(3):281-292. doi: 10.1163/18762891-bja00057.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 subtilis ATCC 122264 in people with Functional Bloating, run by Kerry Group P.L.C 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 10 inclusion and 13 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 15 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?
Effect on intestinal gas symptoms and quality of life (time frame: 8 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 NCT06308146, 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 15 Mar 2024.