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NCT05595980 · ClinicalTrials.gov registry record · NA
The Effects of a Novel Probiotic on Gastrointestinal Health in Generally Healthy Adults
A NA study of Digestive Health and Gastrointestinal Health, sponsored by BIO-CAT Microbials.
- Completed
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT05595980: Completed NA study of Digestive Health and Gastrointestinal Health, sponsored by BIO-CAT Microbials.
NCT05595980 is a NA study of Digestive Health and Gastrointestinal Health that has completed, run by BIO-CAT Microbials. The registered enrollment target is 80 participants, above the 70-participant average among 6 other Digestive Health trials with a reported enrollment target (14% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05595980, a NA study of Digestive Health and Gastrointestinal Health, has completed, sponsored by BIO-CAT Microbials.
- COMPLETED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
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).
Primary Outcome
Between placebo and probiotic treatments, the difference in the proportion of participants with a decrease (indicating improvement) in the 7-day total composite score of abdominal bloating, flatulence, and burping, from baseline to week 8, where an increase in scores (indicating worsening) cannot occur within any of the 3 symptoms (daily Gastrointestinal Tolerance Questionnaire \[GITQ\])
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Probiotic
Study Locations (1)
Illinois
- Biofortis Clinical Research, Inc. - Addison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2022-09-19 |
| Est. Completion | 2023-02-03 |
| Phase | NA |
What the finished NCT05595980 record still lists
NCT05595980 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 70-participant average among 6 other Digestive Health trials with a reported enrollment target (14% higher).
The record links to 3 conditions, with Digestive Health appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05595980 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT05595980 about?
NCT05595980 is a clinical study titled "The Effects of a Novel Probiotic on Gastrointestinal Health in Generally Healthy Adults". 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 stru...
What is the current status of trial NCT05595980?
This trial is currently completed. It is a NA study. The enrollment target is 80 participants. The study started on 2022-09-19. Estimated completion is 2023-02-03.
What conditions does trial NCT05595980 study?
This clinical trial studies the following conditions: Digestive Health, Gastrointestinal Health, Immune Health.
What interventions are being tested in trial NCT05595980?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Probiotic (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05595980?
This trial is sponsored by BIO-CAT Microbials, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05595980 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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