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Safety and Tolerability of Bacillus Subtilis MB40 in Healthy Adult Volunteers

Healthy Participants Clinical Trial

Official title:
Single Center, Clinical Trial Examining the Safety and Tolerability of a Bacillus Subtilis Probiotic in Healthy Adult Volunteers in a Single-Blind Design

Clinical Trial Summary

This study is a single-blind, placebo-lead in design examining the safety and tolerability of a probiotic, Bacillus subtilis MB40. Subjects received a 7-day placebo BID lead-in and a 21-day BID course of Bacillus subtilis MB40. GI questionnaires and Bristol stool charts along with evaluation of any medically significant changes, based on physical examination findings, clinical laboratory tests and vital signs assessments were used to determine the safety and tolerability of MB40.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04655352
Study type Observational
Source BIO-CAT Microbials, LLC
Contact
Status Completed
Phase
Start date October 28, 2015
Completion date December 17, 2015
View Details
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