The Effects of Bifidobacterium-based Probiotics in Reducing Blood Pressure in Middle-aged Chinese… (NCT07206303) | Clinical Trial Compass
Not Yet RecruitingPhase 1
The Effects of Bifidobacterium-based Probiotics in Reducing Blood Pressure in Middle-aged Chinese With Hypertension
Hong Kong30 participantsStarted 2026-05
Plain-language summary
The primary objective of this study is to investigate if a Bifidobacterium-based probiotic intervention would reduce clinic systolic BP in untreated middle-aged Chinese men and women with hypertension according to ACC/AHA guidelines (SBP ≥130 mm Hg) after 12 weeks of treatment. The investigators anticipate that this feasibility study will provide rationale to conduct a larger randomized clinical trial and preliminary data to estimate the power/ sample size of a larger RCT.
Who can participate
Age range40 Years – 65 Years
SexALL
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Inclusion Criteria:
* Men or women, aged 40-65 years old.
* Chinese residing in Hong Kong.
* Clinic SBP ≥130mmHg according to screening measurement at baseline.
* Untreated or not on antihypertensive medications within 4 weeks.
* Able to provide informed consent.
Exclusion Criteria:
* Clinic SBP \>165mmHg according to screening measurement at baseline
* Known history of diabetes, coronary artery disease, stroke, peripheral artery disease, malignancy or chronic kidney disease
* Known history of gastrointestinal disorders including inflammatory bowel disease, irritable bowel syndrome, Helicobacter pylori infection, liver cirrhosis or long-term use of proton pump inhibitors.
* Known increased risk of infection due to endovascular or rheumatic heart disease, endovascular grafts, congenital heart defects, endocarditis, mechanical heart valves, and permanent endovascular devices including permanent (not temporary) hemodialysis catheters, pacemakers, or defibrillators.
* Known secondary causes of hypertension.
* Currently taking omega-3 fatty acid supplements, probiotics, antibiotics, rifaximin, steroids, and antihypertensive agents within 4 weeks.
* Currently taking antibiotics within 6 months.
* Currently taking anti-oxidant vitamins within 6 months.
* Recent travel to tropical areas within 6 months.
* Recent bariatric surgery, hepatic resection, intestinal resection/colectomy, or any surgery within 3 months before the study.
* Identified higher susceptibility to infections cau…
What they're measuring
1
Mean seated clinic systolic blood pressure (SBP)
Timeframe: During clinical visits at: - Baseline (a week prior to treatment), - Week 4, 8 of treatment - Week 12 of treatment (end of treatment)