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(352) 733-0111

Gut Organoid Study

  • Status
    Accepting Candidates
  • Age
    18 Years - 80 Years
  • Sexes
    All
  • Healthy Volunteers
    Accepts Healthy Volunteers
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Objective

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.

Details

Full study title Gut Inflammation and Gut-Gut Microbiome Interactions in the Pathogenesis of Hypertension
Protocol number OCR34622
ClinicalTrials.gov ID NCT04497727

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

Lead researcher

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.