Gut Organoid Study

Completed

• Conditions: Gut Inflammation
• Interventions: Other: Gene Expression

• Registration Number: NCT04497727
• Lead Sponsor: University of Florida

Brief Summary

The study will compare basic properties of gut epithelia of hypertensive and normotensive reference subjects. The study will determine if there are fundamental differences in the gut epithelium in hypertension compared to normotension.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-08-03
• Study First Posted: 2020-08-04
• Study Start: 2021-03-05
• Primary Completion: 2022-04-08
• Study Completion: 2024-04-21
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing routine colonoscopy	Gene Expression	Patients with and without hypertension who routinely undergo colonoscopy

Primary Outcome Measures

Name	Time	Method
Samples with DNA	Visit 1 day	Biopsy specimens (formalin fixed and paraffin embedded) which are routinely obtained during the endoscopic procedure are retained according to legal requirements.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States