Status:
ACTIVE_NOT_RECRUITING
Analysis of MicroBial Metabolites After Eating Refined Food
Lead Sponsor:
The Cleveland Clinic
Conditions:
Dietary Habits
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to learn more about what happens in the human body after consuming a meal that contains ultra-processed foods like hamburgers, and if this is different to what happens aft...
Detailed Description
The purpose of this study is to discover more about how the human body and the bacteria living in our intestines, known as "gut flora," react to different foods a person may consume. The investigators...
Eligibility Criteria
Inclusion
- Men and women age 18 years or above.
- Able to provide informed consent and comply with study protocol
- Able to remain on a stable aspirin regimen (either on or off aspirin or aspirin products) for 1 week prior to starting study until the end of the study period.
Exclusion
- Significant chronic illness or end-organ dysfunction, including known history of uncompensated heart failure, renal failure, pulmonary disease, hematologic diseases.
- Active infection or received antibiotics within 6 months of study enrollment.
- Use of over-the-counter probiotic within past month.
- Chronic gastrointestinal disorders.
- Intolerance to probiotic therapy.
- Allergy to vancomycin, ciprofloxacin, neomycin, metronidazole, or lactose.
- Allergy to any of the food components of the challenge meals.
- Having undergone bariatric procedures or surgeries such as gastric banding or bypass.
- Pregnancy.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04308473
Start Date
September 1 2020
End Date
July 1 2026
Last Update
July 29 2025
Active Locations (1)
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1
Cleveland Clinic Main Campus
Cleveland, Ohio, United States, 44195