Gut Organoid Study

November 16, 2023 updated by: University of Florida

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Hypertensive and normotensive patients who routinely undergo scheduled elective colonoscopy (for different, not selected reasons)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients undergoing routine colonoscopy
Patients with and without hypertension who routinely undergo colonoscopy
Other: Gene Expression
Gene expression analysis of biopsy specimens obtained during routine colonoscopy examination

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Carl Pepine, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2021

Primary Completion (Actual)

April 8, 2022

Study Completion (Estimated)

April 21, 2024

Study Registration Dates

First Submitted

July 28, 2020

First Submitted That Met QC Criteria

August 3, 2020

First Posted (Actual)

August 4, 2020

Study Record Updates

Last Update Posted (Estimated)

November 20, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201903360 -N
  • R01HL132448 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gut Inflammation

Clinical Trials on Gene Expression

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe