NCT04497727

Gut Organoid and Microbiome Interactions in Hypertension

Gut Inflammation and Gut-Gut Microbiome Interactions in the Pathogenesis of Hypertension

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 35 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

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 undergoing routine elective colonoscopy at the University of Florida. Participants were classified into high blood pressure (HBP) and normotensive (REF) groups based on blood pressure criteria defined by the 2017 ACC/AHA guidelines. The study had two primary aims. Aim 1 was to evaluate whether gene expression patterns in the gut epithelium differ between hypertensive and normotensive individuals using RNA sequencing. Aim 2 was to assess whether gut organoids-three-dimensional epithelial cultures derived from colonic biopsies-exhibit different growth rates and proportions, using immunohistochemistry and fluorescence-activated cell sorting (FACS). Biopsy specimens were collected during clinically indicated colonoscopies. Tissue samples were processed immediately after collection: one portion was snap-frozen for RNA isolation and sequencing; the other was used to establish gut organoid cultures. Data were coded and stored in a secure, encrypted database with all identifiers removed to protect confidentiality, in compliance with HIPAA regulations. Although the study protocol initially planned to recruit 60 participants, a total of 35 subjects were successfully enrolled-16 with high blood pressure (HBP) and 19 normotensive (REF) participants. All provided adequate biopsy material for gene expression analysis.

Conditions

• Gut Inflammation
• Hypertension

Interventions

Type	Name	Description
OTHER	Gene Expression	Gene expression analysis of biopsy specimens obtained during routine colonoscopy examination

Timeline

• Start date: 2021-03-05
• Primary completion: 2022-04-08
• Completion: 2024-04-21
• First posted: 2020-08-04
• Last updated: 2025-09-29
• Results posted: 2025-09-29

Locations

1 site across 1 country: United States