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Safety and Tolerability of Bacillus Subtilis MB40 in Healthy Adult Volunteers

NCT04655352 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2022-02-10

No results posted yet for this study

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

  • Healthy Participants

Interventions

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

Sponsors & Collaborators

  • Prism Research LLC

    collaborator UNKNOWN

  • BIO-CAT Microbials, LLC

    lead INDUSTRY

Principal Investigators

  • Mark Matson, MD · Prism Research LLC

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-28
Primary Completion
2015-12-17
Completion
2015-12-17

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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 NCT04655352 on ClinicalTrials.gov