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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up december 2017
Awards & highlights
CARNIVAL Trial 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.Check my eligibility
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.See study design
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.
CARNIVAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ december 2017
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~december 2017
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measure
Secondary outcome measures
Measures
CARNIVAL Trial Design
5Treatment groups
Active Control
Group I: 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 II: 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 III: 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 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.
Find a Location
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,026 Previous Clinical Trials
1,365,976 Total Patients Enrolled
1 Trials studying Dietary Modifications
150 Patients Enrolled for Dietary Modifications
Stanley L Hazen, MD, PhDPrincipal InvestigatorThe Cleveland Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have long-term stomach or bowel problems or can't tolerate probiotics.I do not have serious long-term illnesses like heart or kidney failure.I am 18 years old or older.I have taken OTC probiotics or eaten yogurt recently.I have had weight loss surgery like gastric banding or bypass.I have not had an infection or taken antibiotics in the last 2 months.
Research Study Groups:
This trial has the following groups:- Group 1: Choline and Aspirin
- Group 2: Carnitine and Aspirin
- Group 3: Antibiotics
- Group 4: Carnitine (No antibiotics, No aspirin)
- Group 5: Choline (No Antibiotics, No aspirin)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 40 Other Conditions - This treatment demonstrated efficacy for 40 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What conditions is Carnitine (No antibiotics, No aspirin) typically prescribed for?
"Carnitine (No antibiotics, No aspirin) is normally utilized for pain relief. However, it has also been effective at treating other ailments such as myocardial infarction, otitis externa and urinary tract infection."
Answered by AI
How many participants are taking part in this medical study?
"At this time, no more recruits are being accepted for the trial that was originally posted on February 11th 2011 and last updated September 28th 2022. If you're looking for alternative studies related to dietary modifications there are 425 trials currently enrolling patients and 302 clinicals recruiting based off of Carnitine (No antibiotics, No aspirin) standards."
Answered by AI
Is this particular trial unique in its methodology?
"Presently, 302 clinical trials associated with Carnitine (No antibiotics, No aspirin) are being conducted globally in 64 nations and 1467 cities. The first such trial was funded by Abbott and began in 2005; it included 15480 participants and achieved Phase 4 drug approval prior to closure. Subsequently, 1100 additional studies have taken place since this initial research endeavor."
Answered by AI
Is participation in this research endeavor currently being sought?
"According to clinicaltrials.gov, this medical study has ceased patient recruitment as of 9/28/2022 - the last time it was updated since its first posting on 2/11/2011. Nonetheless, there are still 727 other trials actively looking for participants at present."
Answered by AI
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