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

NCT02872688 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-09-13

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

OTHER

GanedenBC30

Sponsors & Collaborators

  • Ganeden Biotech, Inc.

    collaborator INDUSTRY

  • Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

    lead NETWORK

Principal Investigators

  • Anthony Bier, MD · Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2016-12-19
Completion
2017-04-13

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02872688 on ClinicalTrials.gov