NCT04497727Completed
Gut Organoid and Microbiome Interactions in Hypertension
Gut Inflammation and Gut-Gut Microbiome Interactions in the Pathogenesis of Hypertension
Source: ClinicalTrials.gov · Last updated 29 Sept 2025
Brief summary (registry, in English)
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 hypertension compared to normotension. Specifically, this study examined gene expression profiles of gut organoids derived from biopsy samples of hypertensive and normotensive individuals undergoing clinically indicated colonoscopy.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 35 (actual)
- First submitted
- 28 Jul 2020
- Start date
- 5 Mar 2021
- Primary completion date
- 8 Apr 2022
- Lead sponsor
- University of Florida
- Diseases
- High blood pressure
- NCT number
- NCT04497727
What you commit to
- Study type: Observational
- Participants enrolled: 35
- From 5 Mar 2021 to the primary completion date, 8 Apr 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Hypertensive or reference individuals with history of autoimmune disease or other chronic inflammatory conditions.
- History of intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance, chronic pancreatitis or other malabsorption disorder.
- History of blood transfusion within 4 weeks.
Other
- Pregnant or have been pregnant in the last six months.
- Antibiotic treatment within two months of study enrollment
- Subjects who, in the opinion of the investigator, will be uncooperative or unable to comply with study procedures
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.