Influence of GanedenBC30 (Bacillus Coagulans GBI-30, 6086) on the Gut Microbiome in Healthy Adults

Inclusion criteria

• Non-smoker, or ex-smoker ≥6 months
• Body mass index 18.5- 34.9 kg/m2 (inclusive)
• Female subjects of childbearing potential [i.e. not surgically sterilized or post-menopausal (greater than one year since last menses)] must have negative urine pregnancy test and must be using an effective birth control method
• Willing to avoid alcohol consumption for 24 h prior to every clinic visit
• Willing to maintain their regimens of dietary supplements known to alter GI function (including, but not limited to, iron supplements and calcium)
• Willing to maintain a stable body weight, activity level and dietary pattern except for use of the study products, as directed
• Willing and able to provide informed written consent

Exclusion criteria

• Pregnancy or lactation, or subject unwilling to take appropriate contraceptives for the duration of the study
• Use of prescription drugs (other than birth control) within 1 month prior to visit 1b
• Use of any weight-loss programs or weight-loss medications (prescription or over-the counter) including, but not limited to, lipase inhibitors, within 3 months prior to visit 1b
• Use of over-the-counter or prescription laxatives or stool softeners within 1 month prior to visit 1b
• Use of antibiotics (other than topical) within 2 months prior to visit 1b
• Use of prebiotic supplements (e.g. fructans and galacto-oligosaccharides (GOS), psyllium, fiber, inulin) or probiotic supplements (i.e. live microorganisms) within 1 month of visit 1b or consumption of any yogurts or foods with added prebiotics or added probiotics within 2 weeks of visit 1b
• History of blood clotting disorders or use of coagulation-inhibiting drugs (e.g. warfarin)
• Individuals with achlorhydria
• Presence of any disease (including, but not limited to: diabetes, gastrointestinal disease, cardiovascular disease, pancreatic, renal, or liver disease, chronic diarrhea or constipation, irritable bowel syndrome, or inflammatory bowel disease
• Abdominal or gastrointestinal surgery within the previous 12 months or planned abdominal or gastrointestinal surgery in the next 4 months
• Recent gastrointestinal food-borne illness (within 1 month prior to visit 1b)
• History of neurological disease (e.g. Parkinson's disease, stroke, traumatic brain injury, etc.)
• History of cancer (excluding non-melanoma skin cancer and basal cell carcinoma) in the past 5 years
• Controlled or uncontrolled hypertension defined as a seated resting systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg
• Abnormal laboratory test results of clinical significance, including, but not limited to ALT or AST ≥1.5X the upper limit of normal at screening
• Presence or history (past 6 months) of alcohol or drug abuse; alcohol use of >2 standard alcoholic drinks per day
• Extreme dietary habits (e.g. vegan or very low carbohydrate diets)
• Subject has a known allergy or intolerance to soy
• Allergy or intolerance to or contraindication to both of the rescue antibiotic regimens (Ciprofloxacin and Septra (contains Trimethoprim)
• Subject is unwilling or unable to abide by the requirements of the protocol
• Any condition that would interfere with the subject's ability to comply with study instructions, might confound the interpretation of the study, or put the subject at risk
• Subject has taken an investigational health product or has participated in a research study within 30 days prior to first study visit