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

Healthy Volunteers Clinical Trial

Official title:

A Baseline Controlled, Open Label, Single-arm Study to Investigate the Influence of GanedenBC30 (Bacillus Coagulans GBI-30, 6086) on the Gut Microbiome in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02872688
• Other study ID #: GANERPD-160001-RPD01
• Status: Completed
• Phase: N/A
• First received: August 11, 2016
• Last updated: September 12, 2017
• Start date: August 2016
• Est. completion date: April 13, 2017

Study information

• Verified date: September 2017
• Source: Nutrasource Diagnostics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 13, 2017
• Est. primary completion date: December 19, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• GanedenBC30

Locations

Country	Name	City	State
Canada	Nutrasource Diagnostics Inc.	Guelph	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Nutrasource Diagnostics Inc.	Ganeden Biotech, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with treatment-related adverse events as assessed by MedDRA coding		4 weeks
Primary	Changes in the gut microbiome	Observe changes in the gut microbiome after 4 weeks of supplementation with GanedenBC30 as assessed by 16s RNA sequencing of feces	4 weeks
Secondary	Change in stool frequency		4 weeks
Secondary	Change in stool consistency	Calculated using the Bristol stool scale form rating each bowel movement and averaging over each week	4 weeks
Secondary	Changes severity of bloating as assessed by daily scores using a 4 point Likert scale	Determined using a 4 point Likert scale	4 weeks
Secondary	Changes severity of gas as assessed by daily scores using a 4 point Likert scale		4 weeks
Secondary	Changes severity of abdominal pain as assessed by daily scores using a 4 point Likert scale		4 weeks
Secondary	Changes in feeling of overall well-being as assessed by daily scores using a 5 point Likert scale		4 weeks