Effect of Probiotic Supplementation on Endothelial Function

December 15, 2015 updated by: Medical College of Wisconsin

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

We plan to recruit 20 patients, men with coronary artery disease, for this single center, interventional trial with the Probiotic-GoodBelly followed by Vancomycin. The study includes 6 total visits. Subjects who pass a phone screen will be invited to a screening visit for study eligibility (Visit 1) Informed consent will be reviewed; a unique study number will be assigned once written informed consent is obtained (no subject will be assigned more than 1 allocation number); relevant participant medical history will be recorded including currently prescribed medications; anthropometric measurements will be taken (height, weight, and waist circumference in metric units) and blood pressure will be recorded (measured in triplicate and averaged). Subjects will be allowed to take their blood pressure medication on the morning of their screening visit, but not the mornings of any of the other study visits to limit the acute influence of these medications on endothelial function. If the potential participant qualifies for the study, he will return 1 week after the screen for a study visit(Visit 2) where he will turn in his stool sample, undergo initial tests of endothelial function and receive 3 week supply of GoodBelly Probiotic. After 3 weeks he will have to return (Visit 3) for another 3 week supply of his probiotic. After a total of 6 weeks of taking the probiotic he will have to return (Visit 4) with his stool sample. He will be asked to fast for 6-8 hours prior to the visit to limit the acute dietary influences on vascular endothelial function. During Visit 4, endothelial function will determined by brachial artery reactivity testing His stool samples will be collected and blood samples will also be taken at this visit for systemic measurements inflammatory markers. If he agrees to the optional Vancomycin study. He will return after 4 weeks for (Visit 5). He will be asked to fast for 6-8 hours prior to the visit to limit the acute dietary influences on vascular endothelial function. At Visit 5, endothelial function will determined by brachial artery reactivity testing His stool samples will be collected and blood samples will also be taken at this visit for systemic measurements inflammatory markers. He will then be given a 10 day supply of vancomycin. After 10 days he will return (Visit 6) with his stool sample. At Visit 6, endothelial function will determined by brachial artery reactivity testing . His stool samples will be collected and blood samples will also be taken at this visit for systemic measurements inflammatory markers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwauke, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Age between 40-75 years old
  2. Male sex
  3. History of known coronary artery disease (by either history of myocardial infarction, angiogram demonstrative >=50% stenosis in at least 1 major epicardial coronary artery, or a previous stress test that showed evidence of ischemia that has not been revealed to be a false positive test by angiography)

Exclusion Criteria:

  1. Unstable angina or myocardial infarction by history, ECG, and/or enzymatic criteria within 1 month of enrollment.
  2. Left ventricular dysfunction as defined by an left ventricular ejection fraction documented as < 45% within 1 year of enrollment by an echocardiogram, MRI, or nuclear imaging.
  3. Uncontrolled hypertension with a blood pressure greater than 170/100 mmHg at the screening visit.
  4. 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.
  5. Known history of cognitive impairment or inability to follow study procedures
  6. Patient with an implanted defibrillator or permanent pacemaker on with the potential participant is known to rely upon for greater than 50% of ventricular depolarizations.
  7. Patients who received probiotics, prebiotics, and antibiotics in the last 12 weeks.
  8. Patients with dosing changes of vasoactive medications and 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors in the 6 weeks prior to enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GoodBelly Probiotic and Vancomycin
Good Belly 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
Dietary supplement: GoodBelly Probiotic
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
Drug: Vancomycin
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Brachial Artery Flow Mediated Dilation
Time Frame: % Change before and after 6 weeks of daily Probiotic
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.
% Change before and after 6 weeks of daily Probiotic
Brachial Artery Flow Mediated Dilation
Time Frame: Change before and after 10 days of Vancomycin, approximately 12 weeks from baseline
Flow Mediated Dilation is measured as the percent change in brachial artery diameter as measured by high resolution ultrasound based on arterial diameter prior to and following 5 minute flow occlusion to the forearm . We measured the percent change in brachial diameter before vancomycin was started and again 10 days after vancomycin
Change before and after 10 days of Vancomycin, approximately 12 weeks from baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Interleukin 8
Time Frame: Change before and after 6 weeks of daily Probiotic
Circulating cytokine measured in the plasma
Change before and after 6 weeks of daily Probiotic
Interleukin-12
Time Frame: Change before and after 6 weeks of probiotic
This is a circulating plasma cytokine
Change before and after 6 weeks of probiotic

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical College of Wisconsin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael E Widlansky, MD, Medical College of Wisconsin
  • Principal Investigator: John Baker, PhD, Medical College of Wisconsin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO00019610
  • FP00004156 (Other Identifier: CTSI Advancing a Healthier Wisconsin)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings