Overview
CARNIVAL Study: Gut Flora Dependent Metabolism of Dietary CARNItine and Phosphatidylcholine and cardioVAscuLar Disease
Status:
Enrolling by invitation
Enrolling by invitation
Trial end date:
2025-06-01
2025-06-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The principal goal for the study is to examine the role gut flora plays in modulating metabolism of dietary carnitine and choline in humans.Phase:
Early Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
The Cleveland ClinicTreatments:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Aspirin
Choline
Ciprofloxacin
Metronidazole
Neomycin
Vancomycin
Criteria
Inclusion Criteria:- Men and women age 18 years or above.
- Able to provide informed consent and comply with study protocol
Exclusion Criteria:
- Significant chronic illness or end-organ dysfunction, including known history of heart
failure, renal failure, pulmonary disease, hematologic diseases or pregnancy.
- Active infection or received antibiotics within 2 months of study enrollment
- Use of Over-The-Counter (OTC) probiotic within past 2 months, or ingestion of yogurt
within past 7 days
- Chronic gastrointestinal disorders, or intolerance to probiotic therapy
- Having undergone Bariatric procedures or surgeries such as gastric banding or bypass