N/A
N=35
Gut Organoid and Microbiome Interactions in Hypertension
Gut Inflammation · Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT04497727 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Differential Gene Expression in Gut Epithelium — 29; 6 Differentially expressed gene
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Gene Expression (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Differential Gene Expression in Gut Epithelium |
29; 6 | — |
| PRIMARY Growth Rates of Gut Organoids |
— | — |
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 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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04497727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.