Status:
COMPLETED
Gut Organoid and Microbiome Interactions in Hypertension
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Gut Inflammation
Hypertension
Eligibility:
All Genders
18-80 years
Brief Summary
The study compared basic properties of gut epithelia of hypertensive and normotensive reference subjects. The study determined if there are fundamental differences in the gut epithelium in hypertensio...
Detailed Description
This investigated whether there is a difference in gut epithelia between individuals with and without high blood pressure by comparing colonic biopsy samples from. The study was conducted among adults...
Eligibility Criteria
Inclusion
- Inclusion/exclusion criteria for hypertension participants
- Ages: 18-80 years old with a weight greater than or equal to 110 lbs
- Diagnosis of hypertension or without hypertension for the reference cohort. 2017 ACC/AHA (American College of Cardiology/American Heart Association) definition for hypertension (systolic blood pressure ≥130 mmHg and/or diastolic BP ≥80 mmHg) will be used.
- Scheduled elective colonoscopy
Exclusion
- Hypertensive or reference individuals with history of autoimmune disease or other chronic inflammatory conditions.
- Pregnant or have been pregnant in the last six months.
- Antibiotic treatment within two months of study enrollment
- Currently taking a medication (e.g. antibiotic, anti-inflammatory agents, glucocorticoids, other immune modulating medications, antacids or proton pump inhibitor drugs like Prilosec) known to modify gut microbiota.
- Unwilling to discontinue using probiotics for at least two weeks before scheduled biopsy.
- History of intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance, chronic pancreatitis or other malabsorption disorder.
- History of blood transfusion within 4 weeks.
- Subjects who, in the opinion of the investigator, will be uncooperative or unable to comply with study procedures
Key Trial Info
Start Date :
March 5 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 21 2024
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04497727
Start Date
March 5 2021
End Date
April 21 2024
Last Update
September 29 2025
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610