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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 is a NA study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 215 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03267758
The ClinicalTrials.gov registry entry for NCT03267758 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 215 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Goodbelly first is the first listed.
NCT03267758 reports 0 study locations.
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.
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