Gut Microbiome Clinical Trial
Official title:
The Correlation Between Gut Microbiome-host Interaction and Ventricular Arrhythmias.
This study will enroll 30 subjects recruited from the electrophysiology device clinic at the VA medical center. All patients will have a pre-existing implantable cardioverter defibrillator and a diagnosis of cardiomyopathy with left ventricular systolic function of 35% or less by echocardiogram done within 3 years of the time of enrollment. 10 patients who have had no device-monitored ventricular fibrillation/ ventricular tachycardia for the 3 months prior to recruitment will comprise a group of controls. 20 patients will comprise a group of patients with high burden of ventricular arrhythmias, defined as patients with at least one sustained episode of ventricular tachycardia/ ventricular fibrillation requiring implantable cardioverter-defibrillator therapies in the 3 months preceding study enrollment. This information will be obtained from device interrogation at the time of recruitment. Patients will provide a fecal sample for analysis at the time of enrollment.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | September 1, 2023 |
Est. primary completion date | September 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - • age >18 years-old - competent and willing to provide consent - presence of implantable cardioverter-defibrillator - diagnosis of cardiomyopathy - left ventricular ejection fraction of 35% or less as assessed by echocardiogram within 3 years prior to enrollment Inclusion criteria for control group: • no VT/VF on device interrogation for a period of at least 3 months preceding study enrollment Inclusion criteria for high ventricular arrhythmia burden group: • at least one episode of sustained VT/VF or VT/VF requiring ICD therapies within the preceding 3 months as assessed on device interrogation at the time of study enrollment Exclusion Criteria: - • currently pregnant or have been pregnant in the last 6 months - antibiotic treatment within 5 months of study enrollment (i.e. antibiotic therapy in the two months prior to the 3-month period of analysis for VT/VF) - chronic use of medications/supplements that can potentially affect gut microbiota (i.e. probiotics, anti-inflammatory agents, glucocorticoids, other immune modulating medications, antacids or proton pump inhibitors) - history of intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance, chronic pancreatitis, or other malabsorption disorder |
Country | Name | City | State |
---|---|---|---|
United States | North Florida/South Georgia Veterans Health System | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
North Florida Foundation for Research and Education |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | high burden arrhythmias | : To identify specific gut microbiome characteristics of patients who are prone to clinically significant or high burden of ventricular arrhythmias | initially to 3 months | |
Primary | low burden arrhythmias | To identify specific gut microbiome characteristics of patients with similar conventional risk factors and low burden of ventricular arrhythmias. | initially to 3 months | |
Primary | gut microbiome composition | : To examine changes that occur in the gut microbiome composition after treatment of ventricular arrhythmias. | 3 months |
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