Trials / Completed
CompletedNCT04655352
Safety and Tolerability of Bacillus Subtilis MB40 in Healthy Adult Volunteers
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 30 (actual)
- Sponsor
- BIO-CAT Microbials, LLC · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Bacillus subtilis MB40 | 1-week placebo (maltodextrin and excipients) lead-in followed by 250 mg capsule (5 billion CFU/capsule) administered twice daily for 21 days |
Timeline
- Start date
- 2015-10-28
- Primary completion
- 2015-12-17
- Completion
- 2015-12-17
- First posted
- 2020-12-07
- Last updated
- 2022-02-10
Source: ClinicalTrials.gov record NCT04655352. Inclusion in this directory is not an endorsement.