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Probiotic

Probiotics for Cardiovascular Disease

N/A
Recruiting
Led By Michael Widlansky, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
History of known Diabetes Mellitus Type II as previously diagnosed by patient's provider (ICD-9/10 code)
Must not have
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 a blood pressure greater than 170/100 mmHg at the screening visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 6

Summary

This trial will investigate the effect of a probiotic on various markers related to gut bacteria, heart attack severity, and diabetes. Blood and stool samples will be collected to measure these things.

Who is the study for?
This trial is for adults aged 40-80 with Type II Diabetes and known coronary artery disease, but not severe heart issues or recent heart attacks. Participants should be able to follow the study plan and not have cognitive impairments, uncontrolled high blood pressure, major organ dysfunction, a history of heavy drinking or drug use, or recent probiotic/antibiotic use.
What is being tested?
The trial tests if a probiotic can reduce inflammation markers in the blood and improve blood vessel function in patients with heart disease. It involves taking either the probiotic Goodbelly or a placebo first, providing stool samples for gut bacteria analysis, and undergoing endothelial function tests.
What are the potential side effects?
Probiotics are generally considered safe but may cause digestive discomfort such as gas or bloating initially. Since this is research on their effect on cardiovascular health specifically, monitoring by healthcare professionals will detect any unusual side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a history of significant heart artery disease.
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I have been diagnosed with Type II Diabetes.
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I am between 40 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My heart's pumping ability is below normal.
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My blood pressure is not higher than 170/100 mmHg.
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I have taken probiotics, prebiotics, or antibiotics in the past 3 months.
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My Hgb A1C is above 9.5% and I have a history of heart issues.
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I am pregnant and not taking any Vitamin K antagonists like coumadin or warfarin.
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I have a gastrointestinal condition like short gut syndrome or IBD.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
change in baseline flow mediated dilation (FMD) at 6 weeks

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Goodbelly FirstExperimental Treatment1 Intervention
Subjects in this arm will consume 1 serving of lactobacillus plantarum 299v daily for first 6 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Subjects in this arm will consume 1 serving of heat-killed placebo daily for first 6 weeks.

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
631 Previous Clinical Trials
1,181,743 Total Patients Enrolled
Michael Widlansky, MDPrincipal InvestigatorMedical College of Wisconsin
1 Previous Clinical Trials
21 Total Patients Enrolled

Media Library

Goodbelly (Probiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03267758 — N/A
Type 2 Diabetes Research Study Groups: Goodbelly First, Placebo
Type 2 Diabetes Clinical Trial 2023: Goodbelly Highlights & Side Effects. Trial Name: NCT03267758 — N/A
Goodbelly (Probiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03267758 — N/A
~22 spots leftby Sep 2025
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