Gut Organoid Study

Gut Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04497727
• Other study ID #: IRB201903360 -N
• Secondary ID: R01HL132448
• Status: Active, not recruiting
• Start date: March 5, 2021
• Est. completion date: April 21, 2024

Study information

• Verified date: November 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 41
• Est. completion date: April 21, 2024
• Est. primary completion date: April 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gut Inflammation
• Inflammation

Intervention

Other:
• Gene Expression
Gene expression analysis of biopsy specimens obtained during routine colonoscopy examination

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Samples with DNA	Biopsy specimens (formalin fixed and paraffin embedded) which are routinely obtained during the endoscopic procedure are retained according to legal requirements.	Visit 1 day