Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Cerebral Arterial Diseases
  • Coronary (Artery) Disease
  • Hyperlipidemias
  • Hypertension
  • Peripheral Vascular Diseases
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Prevention

Participation Requirements

Age
Between 21 years and 89 years
Gender
Both males and females

Description

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, we may be abl...

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, we 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. Our pilot study has demonstrated that supplementation of Lactobacillus plantarum 299v (Lp299v) for 6 weeks to adults with a history of coronary artery disease showed improvement in endothelial function. Whether acute ingestion of a single drink containing Lp299v supplementation favorably impacts vascular endothelial function is not known. The study proposed will test the hypothesis that supplementation of Lp299v favorably impacts vascular endothelial function after ingestion of a single supplement containing Lp299v. Specific Aim 1 will determine the acute impact of probiotic supplementation on endothelial cell function as measured by brachial artery flow mediated dilation (FMD) Specific Aim 2 will determine the impact of acute probiotic supplementation on blood biomarkers for inflammation. Specific Aim 3 will be to determine the impact of baseline constitution of intestinal microbiota (assessed by stool microbiome) on change in FMD as a result of acute response to probiotic supplementation. Specific Aim 4 will be to determine the impact of baseline constitution of intestinal microbiota (assessed by stool microbiome) on change in levels of blood markers for inflammation as a result of acute response probiotic supplementation.

Tracking Information

NCT #
NCT04364074
Collaborators
Not Provided
Investigators
Not Provided