A Study to Evaluate OPTI-BIOME™ Bacillus Subtilis MB40 on Abdominal Discomfort, Gas and Bloating in a Healthy Population

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Bloating

Intervention / Treatment
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* Dietary Supplement: OPTI-BIOME™ Bacillus subtilis MB40
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPTI-BIOME™ Bacillus subtilis MB40<br> | Dietary Supplement: OPTI-BIOME™ Bacillus subtilis MB40<br> <br> |
| Placebo Comparator: Placebo<br> | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weekly mean of the daily bloating scores | Discomfort, Gas and Bloating questionnaire | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weekly mean of the daily gas score (flatulence) | Discomfort, Gas and Bloating questionnaire | 4 weeks | 
| Weekly mean of the abdominal pain score | Discomfort, Gas and Bloating questionnaire | 4 weeks | 
| Modified Gastrointestinal Symptom Rating Scale (GSRS) score |  | 4 weeks | 
| Weekly mean stool consistency scores | Bristol stool scale | 4 weeks | 
| Weekly mean number of bowel movements | Daily Bowel Habits Diary | 4 weeks | 
| Quality of Life | Rand SF-36 | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy, Bloating, Abdominal Discomfort, Gas, Probiotic, Bacillus Subtillis