Coronary Artery DiseasePhase 4NCT01952834
Effect of Probiotic Supplementation on Endothelial Function
A Phase 4 study testing GoodBelly Probiotic and Vancomycin in people with Coronary Artery Disease, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- GoodBelly Probiotic and Vancomycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Mar 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40-75 years old
- Male sex
- 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)
Who cannot join
- Unstable angina or myocardial infarction by history, ECG, and/or enzymatic criteria within 1 month of enrollment.
- 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.
- Uncontrolled hypertension with a 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 with 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 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors in the 6 weeks prior to enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwauke, Wisconsin, 53226
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- GoodBelly Probiotic, Vancomycin
- Keywords
- coronary artery disease, probiotic, endothelial function, brachial artery, ntric oxide
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GoodBelly ProbioticDietary supplement
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
| Study group | Role | What they receive |
|---|---|---|
| GoodBelly Probiotic and Vancomycin | Experimental | 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 Receives: Dietary Supplement: GoodBelly Probiotic; Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial Artery Flow Mediated Dilation
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.
Measured: % Change before and after 6 weeks of daily Probiotic
Brachial Artery Flow Mediated Dilation
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
Measured: Change before and after 10 days of Vancomycin, approximately 12 weeks from baseline
Secondary outcomes (2)
Interleukin 8
Circulating cytokine measured in the plasma
Measured: Change before and after 6 weeks of daily Probiotic
Interleukin-12
This is a circulating plasma cytokine
Measured: Change before and after 6 weeks of probiotic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael E Widlansky, MD, Principal investigator, Medical College of WisconsinJohn Baker, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952834
- Sponsor's protocol ID
- PRO00019610
- Other IDs
- FP00004156
- Status last verified
- Dec 2015
- First submitted
- 24 Sep 2013
- Last updated
- 21 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Malik M, Suboc TM, Tyagi S, Salzman N, Wang J, Ying R, Tanner MJ, Kakarla M, Baker JE, Widlansky ME. Lactobacillus plantarum 299v Supplementation Improves Vascular Endothelial Function and Reduces Inflammatory Biomarkers in Men With Stable Coronary Artery Disease. Circ Res. 2018 Oct 12;123(9):1091-1102. doi: 10.1161/CIRCRESAHA.118.313565.
PubMed 30355158
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic Supplementation on Endothelial Function in Men With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01952834
- Acronym / sponsor ID
- PRO00019610
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, probiotic, endothelial function, brachial artery, ntric oxide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 30 Sep 2013 (estimated)
- Results
- Posted 21 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GoodBelly Probiotic and Vancomycin | Experimental | Dietary Supplement: GoodBelly Probiotic, Drug: VancomycinGood 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 |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 40-75 years old
- Male sex
- 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)
Key exclusion criteria (8 listed)
- Unstable angina or myocardial infarction by history, ECG, and/or enzymatic criteria within 1 month of enrollment.
- 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.
- Uncontrolled hypertension with a 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GoodBelly ProbioticGoodBelly 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 and Vancomycin |
| VancomycinGoodBelly 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 | GoodBelly Probiotic and Vancomycin |
Primary outcome
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.
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
2 secondary outcomes
Interleukin 8
Time frame: Change before and after 6 weeks of daily Probiotic
Interleukin-12
Time frame: Change before and after 6 weeks of probiotic
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30355158Malik M, Suboc TM, Tyagi S, Salzman N, Wang J, Ying R, Tanner MJ, Kakarla M, Baker JE, Widlansky ME. Lactobacillus plantarum 299v Supplementation Improves Vascular Endothelial Function and Reduces Inflammatory Biomarkers in Men With Stable Coronary Artery Disease. Circ Res. 2018 Oct 12;123(9):1091-1102. doi: 10.1161/CIRCRESAHA.118.313565.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael E Widlansky, MD principal investigator
Medical College of Wisconsin
John Baker, PhD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GoodBelly Probiotic and Vancomycin in people with Coronary Artery Disease, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial Artery Flow Mediated Dilation (time frame: % Change before and after 6 weeks of daily Probiotic). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01952834, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2016.