Status:
COMPLETED
Acute Probiotic Supplementation and Endothelial Function
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Coronary Artery Disease
Hypertension
Eligibility:
All Genders
21-89 years
Phase:
NA
Brief Summary
One in every two deaths in the United States is caused by cardiovascular disease. Despite strong mechanistic links established between a diet rich in lipids and the pathogenesis of cardiovascular dise...
Detailed Description
Researchers at MCW have discovered a new pathway that links the type of bacteria present in the intestines to the severity of heart attacks. This discovery of a relationship between intestinal bacteri...
Eligibility Criteria
Inclusion
- Have at least one of the following conditions:
- Hypertension
- Hyperlipidemia
- Diabetes mellitus (Type 1 or Type 2)
- Peripheral vascular disease
- Cerebrovascular disease
- Cardiovascular disease.
Exclusion
- Unstable angina or myocardial infarction by history, ECG, and/or enzymatic criteria within 1 month of enrollment.
- LV dysfunction as defined by an LV ejection fraction documented as \< 45% within 1 year of enrollment by an echocardiogram, MRI, or nuclear imaging.
- Uncontrolled hypertension with blood pressure greater than 170/100 mmHg at the screening visit.
- Known history of chronic renal insufficiency, liver dysfunction, or cancer besides non-melanoma skin carcinomas or localized prostate cancer requiring systemic treatment within five years of enrollment.
- Known history of cognitive impairment or inability to follow study procedures
- Patient with an implanted defibrillator or permanent pacemaker on which the potential participant is known to rely upon for greater than 50% of ventricular depolarizations.
- Patients who received probiotics, prebiotics, and antibiotics in the last 12 weeks.
- Patients with dosing changes of vasoactive medications and HMG-CoA reductase inhibitors in the 6 weeks prior to enrollment.
- Pregnancy
- Patients who are currently taking Vitamin K antagonists such as coumadin, warfarin.
- Those who are daily drinkers.
- Patients with gastrointestinal diseases that might alter the impact of a probiotic (e.g. status post colectomy, short gut syndrome, or inflammatory bowel disease)
Key Trial Info
Start Date :
August 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2023
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04364074
Start Date
August 17 2020
End Date
August 3 2023
Last Update
August 22 2023
Active Locations (1)
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1
Medical College of Wisconsin
Wauwatosa, Wisconsin, United States, 53222