Actively Recruiting
Antihypertensive Mechanisms of Minocycline in Resistant Hypertension: Role of the Gut Microbiota-brain-immune Axis
Led by University of Florida · Updated on 2026-03-06
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
E
Emory University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how minocycline affects blood pressure in adults with treatment-resistant hypertension. The study aims to determine to what degree minocycline lowers blood pressure and whether these effects involve changes in the gut microbiota, gut leakiness, systemic inflammation, neuroinflammation, or a combination of these factors. This phase 4 clinical trial includes a neuroimaging substudy to explore brain-related impacts. Participants will be randomly assigned to receive either minocycline hydrochloride 100 mg twice daily or a matching placebo, both given for 3 months. The study includes three visits: screening, randomization, and a 3-month follow-up. Those in the neuroimaging substudy will undergo PET/MR imaging at each visit. Throughout the study, participants will undergo medical exams, behavioral questionnaires, blood tests for various biomarkers, urine and saliva tests to assess adherence, stool sample analysis for gut microbiota, and blood pressure monitoring including unattended office and 24-hour ambulatory measurements. At the final visit, blood will also be tested for drug concentration to confirm treatment adherence. The main outcomes measured include 24-hour systolic blood pressure, gut microbiome changes, gut inflammation and leakiness, and neuroinflammation.
CONDITIONS
Brief Title
Antihypertensive Mechanisms of Minocycline in Resistant Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Uncontrolled treatment-resistant hypertension with mean 24-hour ambulatory systolic BP of at least 125 mm Hg or diastolic BP of at least 80 mm Hg
- On a stable antihypertensive regimen of 3 or more drugs including an adequately dosed diuretic or unable to tolerate a diuretic
- Agreement to undergo all study procedures
You will not qualify if you...
- Known hypersensitivity or contraindication to minocycline or other tetracyclines
- Recent (within 3 months), ongoing, or expected use of oral antibiotics
- Estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73m2
- Known secondary hypertension
- History of hypertensive crisis requiring hospitalization within the past year
- History of orthostatic hypotension episodes in the past year
- History of myocardial infarction, unstable angina, syncope, or stroke in the prior 6 months
- Evidence of alcoholism or drug abuse
- Severe comorbid conditions such as neoplasms or HIV/AIDS
- Current pregnancy or anticipated pregnancy during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants take minocycline 100 mg twice daily or placebo for 3 months while undergoing various assessments.
2 visits (baseline and 3-month follow-up, in-person)
Trial Site Locations
Total: 1 location
1
UF Clinical Research Center (UF CRC) - CTSI
Gainesville, Florida, United States, 32610
Actively Recruiting
Research Team
J
Joshua N Terrell
D
David B Smith
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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