The Effects of Bifidobacterium-based Probiotics in Reducing Blood Pressure in Middle-aged Chinese With Hypertension
Key facts
- Where
- Hong Kong, HongkongSee the site
- Phase
- 1. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 65 years old?
Where in Hongkong
- The University of Hong KongHong Kong, HongkongNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The University of Hong Kong
- Trial code
- NCT07206303
- Record updated
- 2026. augusztus 31.
- Original description
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.Read full original descriptionShow less
The Effects of Bifidobacterium-based Probiotics in Reducing Blood Pressure in Middle-aged Chinese With Hypertension: a Single-arm Feasibility Pilot Study
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.
Inclusion: 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: Currently taking omega-3 fatty acid supplements, probiotics, rifaximin, steroids, and antihypertensive agents within 4 weeks; Currently taking antibiotics within 6 months; Currently taking anti-oxidant vitamins within 6 months; Recent bariatric surgery, hepatic resection, intestinal resection/colectomy, or any surgery within 3 months before the study; Intending to participate or have participated in a clinical or nutritional intervention study in the last 30 days before study enrolment; 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; Known allergies to any of the components of Bifidobacterium-based probiotics supplement; Identified higher susceptibility to infections caused by immunosuppression, such as a history of organ or hematopoietic stem cell (HSCs) transplant, neutropenia (ANC <500 cells/µl), HIV, and CD4 <200 cells/µl; Clinic SBP >165mmHg according to screening measurement at baseline; Recent travel to tropical areas within 6 months; Women who are pregnant, or intending to become pregnant, or lactation.