CARNIVAL Study: Gut Flora Dependent Metabolism of Dietary CARNItine and Phosphatidylcholine and cardioVAscuLar Disease

• Status: Enrolling by invitation
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: 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 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Cleveland Clinic
• Treatments: 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