Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04655352
Status:
COMPLETED
Last Update Posted:
2022-02-10
First Post:
2020-11-30
Brief Title:
Safety and Tolerability of Bacillus Subtilis MB40 in Healthy Adult Volunteers
Sponsor:
BIO-CAT Microbials LLC
Organization:
BIO-CAT Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None