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Probiotic

Probiotic for Gastrointestinal Health

N/A
Waitlist Available
Led By Dawn Beckman, MD
Research Sponsored by BIO-CAT Microbials, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 57
Awards & highlights

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).

Eligible Conditions
  • Gastrointestinal Health
  • Immune Health
  • Digestive Health

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 57
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 57 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite score of abdominal bloating, flatulence, and burping (daily GITQ)
Secondary outcome measures
Colonic permeability
Composite score of 8 GI symptoms (7-day recall GITQ)
Composite score of 8 GI symptoms (daily GITQ)
+43 more
Other outcome measures
Feces

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ProbioticExperimental Treatment1 Intervention
Bacillus strain spore preparation
Group II: PlaceboPlacebo Group1 Intervention
Placebo maltodextrin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Probiotic
2013
Completed Phase 4
~3570

Find a Location

Who is running the clinical trial?

BIO-CAT Microbials, LLCLead Sponsor
4 Previous Clinical Trials
243 Total Patients Enrolled
1 Trials studying Gastrointestinal Health
76 Patients Enrolled for Gastrointestinal Health
Biofortis Clinical Research, Inc.Industry Sponsor
11 Previous Clinical Trials
1,018 Total Patients Enrolled
1 Trials studying Gastrointestinal Health
76 Patients Enrolled for Gastrointestinal Health
Ohio State UniversityOTHER
828 Previous Clinical Trials
505,671 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To whom is admittance to this experiment open?

"Patients must satisfy the digestive health criteria and fall between 30-65 years old to be eligible for this study. Approximately 80 people are being recruited in total."

Answered by AI

How many participants is this experiment limited to?

"Indeed, clinicaltrials.gov confirms that this study is in the process of enrolling patients. It was first listed on September 19th 2022 and most recently updated on October 24th 2022. Researchers are aiming to recruit 80 people from one medical centre."

Answered by AI

What is the current status of patient recruitment for this research endeavor?

"Affirmative. The clinical trial profile hosted on the website clinicaltrials.gov attests to this study's active recruitment status, with a first post date of September 19th 2022 and an update as recent as October 24th 2022. Currently, 80 volunteers are being sought out from one medical facility."

Answered by AI

Is this experiment open to individuals under the age of 70?

"This research is calling for volunteers who are between 30 and 65 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Effects of a Novel Probiotic on Gastrointestinal Health in Generally Healthy Adults
2022. "The Effects of a Novel Probiotic on Gastrointestinal Health in Generally Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05595980.
~31 spots leftby Apr 2025
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