Gut InflammationNCT04497727
Gut Organoid and Microbiome Interactions in Hypertension
An observational study of Gut Inflammation and Hypertension, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Inflammation, Hypertension
- What is being tested?
- Gene Expression
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2021to 21 Apr 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hypertensive and normotensive patients who routinely undergo scheduled elective colonoscopy (for different, not selected reasons)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gut Inflammation and Gut-Gut Microbiome Interactions in the Pathogenesis of Hypertension
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.
Read the 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
- Being tested
- Gene Expression
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gene ExpressionOther
Gene expression analysis of biopsy specimens obtained during routine colonoscopy examination
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing routine colonoscopy | Participants were adults undergoing routine screening colonoscopy who met study eligibility criteria and provided written informed consent. Based on their blood pressure status, participants were categorized into two groups: individuals without hypertension (normotensive group) and individuals with high blood pressure (hypertensive group), defined according to the 2017 ACC/AHA guidelines Receives: Other: Gene Expression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential Gene Expression in Gut Epithelium
Number of differentially expressed genes identified through RNA sequencing of colonic epithelial tissue obtained during colonoscopy. Expression profiles were compared between individuals with High Blood pressure (HBP) (hypertensive group) and normotensive reference (REF) participants. Genes were considered differentially expressed if they met criteria of false discovery rate (FDR)-adjusted p-value < 0.05 and absolute fold change ≥ 1.5.
Measured: At time of colonoscopy (single visit)
Growth Rates of Gut Organoids
To compare growth rates and proportions of gut organoids derived from High Blood pressure (HBP) vs. normotensive (REF) participants.
Measured: Within days to weeks post-biopsy (in vitro culture period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start5 Mar 2021
- Primary completion8 Apr 2022
- Study completion21 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gut InflammationStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Carl Pepine, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497727
- Sponsor's protocol ID
- IRB201903360 -N
- Other IDs
- R01HL132448
- Status last verified
- Aug 2025
- First submitted
- 28 Jul 2020
- Last updated
- 29 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Inflammation and Gut-Gut Microbiome Interactions in the Pathogenesis of Hypertension
- ClinicalTrials.gov ID
- NCT04497727
- Acronym / sponsor ID
- IRB201903360 -N
- Conditions
- Gut Inflammation, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 8 Apr 2022 (actual)
- Study completion
- 21 Apr 2024 (actual)
- First posted
- 4 Aug 2020 (actual)
- Results
- Posted 29 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing routine colonoscopy | – | Other: Gene ExpressionParticipants were adults undergoing routine screening colonoscopy who met study eligibility criteria and provided written informed consent. Based on their blood pressure status, participants were categorized into two groups: individuals without hypertension (normotensive group) and individuals with high blood pressure (hypertensive group), defined according to the 2017 ACC/AHA guidelines |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hypertensive and normotensive patients who routinely undergo scheduled elective colonoscopy (for different, not selected reasons)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gene ExpressionGene expression analysis of biopsy specimens obtained during routine colonoscopy examination | Other | Patients undergoing routine colonoscopy |
Primary outcome
Differential Gene Expression in Gut Epithelium
Time frame: At time of colonoscopy (single visit)
Number of differentially expressed genes identified through RNA sequencing of colonic epithelial tissue obtained during colonoscopy. Expression profiles were compared between individuals with High Blood pressure (HBP) (hypertensive group) and normotensive reference (REF) participants. Genes were considered differentially expressed if they met criteria of false discovery rate (FDR)-adjusted p-value < 0.05 and absolute fold change ≥ 1.5.
Growth Rates of Gut Organoids
Time frame: Within days to weeks post-biopsy (in vitro culture period)
To compare growth rates and proportions of gut organoids derived from High Blood pressure (HBP) vs. normotensive (REF) participants.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl Pepine principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gut Inflammation and Hypertension, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differential Gene Expression in Gut Epithelium (time frame: At time of colonoscopy (single visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.