A Study to Evaluate OPTI-BIOME™ Bacillus Subtilis MB40 on Abdominal Discomfort, Gas and Bloating in a Healthy Population
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ClinicalTrials.gov Identifier: NCT02950012
Recruitment Status : Unknown
Verified December 2016 by Dr. Tetyana Pelipyagina, BIO-CAT Microbials, LLC. Recruitment status was: Recruiting
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Study Start Date :
Estimated Primary Completion Date :
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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)
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
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
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