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NCT03267758 · ClinicalTrials.gov registry record · NA
Effect of Probiotic Supplementation on Endothelial Function II
A NA study, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- NA
- Development phase
- 215
- Enrollment target
NCT03267758: Completed NA study, sponsored by Medical College of Wisconsin.
NCT03267758 is a NA study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 215 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03267758, a NA study, has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- NA
- Development phase
- 215 participants
- Enrollment target
Study Summary
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 bacteria, bacterial metabolites, and severity of heart attacks means that for the first time, the investigators may be able to determine a person's probability of having a heart attack via non-conventional risk factors. This may provide opportunities for novel diagnostic tests as well as a potential for therapeutic intervention. The link between gut microbiota and the severity of heart attacks may also lead to novel therapeutic approaches (probiotics, non-absorbable antibiotics) to prevent heart attacks from happening. The studies proposed will test the hypothesis that altered intestinal microbiota are mechanistically linked to the pathogenesis of cardiovascular disease. The investigator's objective is to determine whether inflammatory markers in the blood are decreased and endothelial cell function improved by a probiotic in patients with established coronary artery disease. Furthermore, the investigators wish to elucidate a mechanism by which the gut microbiota regulates serum inflammatory markers. 1. Specific Aim 1 will determine the impact of a probiotic on circulating leptin and TMAO levels, conventional risk factors for cardiovascular disease and diabetes (total cholesterol, LDL cholesterol, oxidized LDL, triglycerides, C-reactive protein, serum amyloid A, fibrinogen and adiponectin, glucose-dependent- insulinotropic polypeptide (GIP), glucagon-like-peptide (GLP-1), glucagon, insulin), and their relationship to the intestinal microbiota (15 representative microbial groups) as non conventional risk factors. Several blood samples will be collected to measure biomarkers. Participants will provide periodic stool samples in order to measure gut bacterial biodiversity. Lastly, endothelial cell function (flow mediated dilation) will be measured in order to assess blood vessel
Primary Outcome
This is a measurement of endothelial function in the brachial artery
Interventions
- DIETARY_SUPPLEMENT Goodbelly first
- DIETARY_SUPPLEMENT Placebo first
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2018-05-15 |
| Est. Completion | 2025-10-16 |
| Phase | NA |
What the finished NCT03267758 record still lists
NCT03267758 is an interventional study that assigns participants to a tested intervention. The registered 215 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Goodbelly first is the first listed.
NCT03267758 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03267758 about?
NCT03267758 is a clinical study titled "Effect of Probiotic Supplementation on Endothelial Function II". 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 bacteria, bacterial metabolites, and severity of heart attacks means that for the first time, the investiga...
What is the current status of trial NCT03267758?
This trial is currently completed. It is a NA study. The enrollment target is 215 participants. The study started on 2018-05-15. Estimated completion is 2025-10-16.
What interventions are being tested in trial NCT03267758?
The interventions under investigation include: Goodbelly first (DIETARY_SUPPLEMENT), Placebo first (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03267758?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03267758's enrollment target sits among peer trials
215 487th of 2000 higher than 1,514 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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