CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 21 enrolled
Drug / intervention
Vancomycin +1 moredrug
Likely dose
Vancomycin 250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01952834
NCT01952834Phase 4Completed

Effect of Probiotic Supplementation on Endothelial Function in Men With Coronary Artery Disease

Medical College of Wisconsin·interventional·Posted Sep 30, 2013·Updated Jan 21, 2016

In Brief

A Phase 4 clinical trial evaluating GoodBelly Probiotic and Vancomycin for Coronary Artery Disease. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 30, 2013
Enrollment StartJun 1, 2013
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.8 years ago

Interventions

GoodBelly Probioticdietary

GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days

Vancomycindrug

GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days