A Study to Evaluate OPTI-BIOME™ Bacillus Subtilis MB40 on Abdominal Discomfort, Gas and Bloating … (NCT02950012) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate OPTI-BIOMEâ„¢ Bacillus Subtilis MB40 on Abdominal Discomfort, Gas and Bloating in a Healthy Population
United States, Canada100 participantsStarted 2016-10
Plain-language summary
The purpose of this study is to investigate the effects of OPTI-BIOMEâ„¢ (Bacillus subtilis MB40), a probiotic supplement, on bloating, gas and abdominal discomfort symptoms in otherwise healthy adults.
Who can participate
Age range18 Years – 75 Years
SexALL
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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.
✓. 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
✓. 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
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)