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NCT01952834 · ClinicalTrials.gov registry record · Phase 4
Effect of Probiotic Supplementation on Endothelial Function
A Phase 4 study, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- Phase 4
- Development phase
- 21
- Enrollment target
NCT01952834: Completed Phase 4 study, sponsored by Medical College of Wisconsin.
NCT01952834 is a Phase 4 study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 21 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01952834, a Phase 4 study, has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 21 participants
- Enrollment target
Study Summary
The study is being performed to determine whether probiotics (GoodBelly) improves blood vessel function.Probiotics similar to yogurt are living micro-organisms (beneficial to its host) the lives in the intestine. Patients who have coronary artery disease will be enrolled in this study. The research results will be used to determine if the type of bacteria present in the intestines play a role in the pathogenesis of cardiovascular disease. Patients with coronary artery disease will be enrolled for up to 12 weeks. Patients will take the probiotic for 6 weeks. Following the 6 week period there is a washout period of 4 weeks, and an optional antibiotic study called vancomycin. Patients will take the vancomycin for 10 days. Blood vessel function will be measured by ultrasound before and after the probiotic supplement and vancomycin antibiotic. Blood will also be taken before and after to evaluate for markers of inflammation.
Primary Outcome
A measurement of endothelial function in humans that reports the percent change in brachial artery diameter to a flow stimulus in the arm induced by 5 minutes of occlusion of flow to the arm. It is measured as the percent change from baseline diameter.
Interventions
- DRUG Vancomycin
- DIETARY_SUPPLEMENT GoodBelly Probiotic
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2013-06 |
| Est. Completion | 2015-03 |
| Phase | Phase 4 |
What the finished NCT01952834 record still lists
NCT01952834 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Vancomycin is the first listed.
NCT01952834 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01952834 about?
NCT01952834 is a clinical study titled "Effect of Probiotic Supplementation on Endothelial Function". The study is being performed to determine whether probiotics (GoodBelly) improves blood vessel function.Probiotics similar to yogurt are living micro-organisms (beneficial to its host) the lives in the intestine. Patients who have coronary artery disease will be enrolled in this study. The research ...
What is the current status of trial NCT01952834?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 21 participants. The study started on 2013-06. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01952834?
The interventions under investigation include: Vancomycin (DRUG), GoodBelly Probiotic (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01952834?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01952834's enrollment target sits among peer trials
21 1742nd of 2000 higher than 248 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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