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Dietary Supplement

Gut Flora Metabolism of Carnitine and Choline for Cardiovascular Disease (CARNIVAL Trial)

Phase < 1

Waitlist Available

Led By Stanley L Hazen, MD, PhD

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Chronic gastrointestinal disorders, or intolerance to probiotic therapy

Significant chronic illness or end-organ dysfunction, including known history of heart failure, renal failure, pulmonary disease, hematologic diseases or pregnancy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up december 2017

Awards & highlights

Approved for 40 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial will examine how gut flora affects the metabolism of carnitine and choline in humans.

Who is the study for?

The CARNIVAL Study is for men and women aged 18 or older who can follow the study's rules. It's not for those with recent infections, antibiotic use within 2 months, chronic gut issues, intolerance to probiotics, serious illnesses like heart failure or pregnancy, past stomach surgeries, or recent use of probiotics including yogurt.

What is being tested?

This study looks at how gut bacteria affect the body's processing of carnitine and choline from food. Participants will receive different combinations of carnitine, choline, antibiotics, and aspirin to see how these influence cardiovascular health.

What are the potential side effects?

Possible side effects may include digestive changes due to antibiotics and aspirin such as upset stomach or diarrhea. Carnitine and choline might cause fishy body odor or increased risk of heart disease if metabolized improperly.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have long-term stomach or bowel problems or can't tolerate probiotics.

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I do not have serious long-term illnesses like heart or kidney failure.

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I have had weight loss surgery like gastric banding or bypass.

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I have not had an infection or taken antibiotics in the last 2 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ december 2017

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~december 2017

This trial's timeline: 3 weeks for screening, Varies for treatment, and december 2017 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measure

Secondary study objectives

Measures

Awards & Highlights

Approved for 40 Other Conditions

This treatment demonstrated efficacy for 40 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Active Control

Group I: Carnitine and AspirinActive Control1 Intervention

Carnitine supplement 500 mg capsule by mouth, twice daily for 2 months Drug: aspirin 81 mg by mouth, daily for 3 months (on aspirin for 1 month prior to starting study and 2 months with Carnitine supplementation during study) Other Names: Ecotrin, Bufferin, Ascriptin, Fasprin, Norwich Aspirin, Durlaza, Bayer Genuine Aspirin, Genacote, Bayer, Halfprin, Aspirtab, Aspir Low, Aspir-Trin

Group II: AntibioticsActive Control1 Intervention

Antibiotics (Ciprofloxacin, Vancomycin, Metronidazole and Neomycin) Drug: Ciprofloxacin 500 mg, po, twice daily for 7 days (Other Names: Cipro) Drug: Metronidazole 500 mg, po, twice daily for 7 days (Other Names: Flagyl, Noritate, Rosadan, Vandazole, Flagyl ER, Vitazol) Drug: Vancomycin 125 mg, po, 4 times daily for 7 days (Other Names: Vancocin, Vancocin HCl, Pulvules, Vancoled, Novaplus, PremierPro Rx, Vancomycin HCl) Drug: Neomycin 1 gram, po, four times daily for 7 days (Other Names: Aminoglycoside)

Group III: Choline and AspirinActive Control1 Intervention

Choline supplement 500 mg capsule by mouth, twice daily for 2 months Drug: aspirin 81 mg by mouth, daily for 3 months (on aspirin for 1 month prior to starting study and 2 months with Choline supplementation during study) Other Names: Ecotrin, Bufferin, Ascriptin, Fasprin, Norwich Aspirin, Durlaza, Bayer Genuine Aspirin, Genacote, Bayer, Halfprin, Aspirtab, Aspir Low, Aspir-Trin

Group IV: Carnitine (No antibiotics, No aspirin)Active Control1 Intervention

L-Carnitine 500 mg capsule by mouth, twice daily for 2 months. No aspirin for 1 month prior to starting study and remains off aspirin during study.

Group V: Choline (No Antibiotics, No aspirin)Active Control1 Intervention

Choline 500 mg capsule by mouth, twice daily for 2 months. No aspirin for 1 month prior to starting study and remains off aspirin during study.

0 / 4Eligibility criteria met