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

Nutrasource

Status

Completed

Conditions

Healthy Volunteers

Treatments

Other: GanedenBC30

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT02872688

GANERPD-160001-RPD01

Details and patient eligibility

About

The purpose of this study is to investigate the effect of a GanedenBC30, a probiotic bacteria (Bacillus coagulans strain GBI-30, 6086), on the gut microbiome in healthy adults. Subjects will complete a 2-week run-in period prior to receiving GanedenBC30. The study is open-label and subjects will act as their own controls as the microbiome is unique to individuals. During the run-in period, subjects will collect two stool samples and complete daily bowel habit diaries in order to understand usual habits and profile the microbiome for each subject. 30 subjects will take part in this research study conducted at Nutrasource Diagnostics Inc. Subjects will take GanedenBC30 for four weeks. Stool samples will be collected at the end of the study and daily bowel habit diaries maintained for the duration of the study.

Enrollment

30 patients

Sex

All

Ages

25 to 50 years old

Volunteers

Accepts Healthy Volunteers

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