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The Effects of a Novel Probiotic on Gastrointestinal Health in Generally Healthy Adults

NCT05595980 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-02-06

No results posted yet for this study

Summary

The primary objective of this study is to investigate the effect of an oral probiotic (Bacillus sp. spore preparation) on abdominal bloating, flatulence, and burping in generally healthy adults. Secondary outcomes include intestinal barrier integrity and fecal microbiome properties (taxonomical structure, diversity, and function).

Conditions

  • Gastrointestinal Health
  • Immune Health
  • Digestive Health

Interventions

DIETARY_SUPPLEMENT

Probiotic

Participants will consume 1 capsule containing 2 billion CFU of a Bacillus strain spore preparation once daily for 56 days

DIETARY_SUPPLEMENT

Placebo

Participants will consume 1 capsule containing maltodextrin once daily for 56 days

Sponsors & Collaborators

  • Biofortis Clinical Research, Inc.

    collaborator INDUSTRY

  • Ohio State University

    collaborator OTHER

  • 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
2022-09-19
Primary Completion
2023-02-03
Completion
2023-02-03

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 NCT05595980 on ClinicalTrials.gov