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Effect of Bacillus Subtilis BS50 Supplementation on Gastrointestinal Symptoms in Healthy Adults

NCT05004454 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2023-01-05

No results posted yet for this study

Summary

The primary objective of this study is to investigate the effect of a novel Bacillus subtilis spore preparation on abdominal bloating, flatulence, and burping in healthy adults.

Conditions

  • Gastrointestinal Health
  • Immune Health
  • Cardiovascular Health
  • Digestive Health

Interventions

DIETARY_SUPPLEMENT

Bacillus subtilis BS50 spore preparation

Subjects will consume 1 capsule containing 2x10⁹ CFU of a Bacillus subtilis BS50 spore preparation once daily for 42 days.

DIETARY_SUPPLEMENT

Maltodextrin

Subjects will consume 1 capsule containing maltodextrin once daily for 42 days.

Sponsors & Collaborators

  • Biofortis Clinical Research, Inc.

    collaborator INDUSTRY

  • BIO-CAT Microbials, LLC

    lead INDUSTRY

Principal Investigators

  • Dawn Beckman, MD · Biofortis Clinical Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-19
Primary Completion
2021-11-08
Completion
2021-11-08

Countries

  • United States

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 NCT05004454 on ClinicalTrials.gov