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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and week 6

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and week 6

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

609 Previous Clinical Trials

1,162,368 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of participation in this investigational trial?

"Affirmative. Clinicaltrials.gov has documented that this experiment commenced recruitment on May 15th 2018 and was last revised on December 2nd 2021, presently seeking 215 participants at a single site."

Answered by AI

Are there any openings for me to partake in this medical study?

"This research study is recruiting 215 diabetic patients aged 40 to 80. The inclusion criteria for coronary artery disease sufferers are: age between 40 and 80, history of myocardial infarction or angiographic evidence of at least 50% stenosis in a major epicardial coronary artery; or positive stress test results not contradicted by subsequent angiography. For non-CAD diabetes mellitus type II individuals the requirement is an age range from 40 -80, with prior diagnosis as recorded in ICD-9/10 codes."

Answered by AI

Is enrollment still available for those interested in the trial?

"According to clinicaltrials.gov, this research endeavour is actively seeking participants and has been available since May 15th 2018 with latest updates on December 2nd 2021."

Answered by AI