NCT07206303Not yet recruitingPhase 1
The Effects of Bifidobacterium-based Probiotics in Reducing Blood Pressure in Middle-aged Chinese With Hypertension
The Effects of Bifidobacterium-based Probiotics in Reducing Blood Pressure in Middle-aged Chinese With Hypertension: a Single-arm Feasibility Pilot Study
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 25 Sept 2025
- Start date
- Nov 2026
- Primary completion date
- Nov 2027
- Lead sponsor
- The University of Hong Kong
- Diseases
- High blood pressure
- NCT number
- NCT07206303
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 30
- From Nov 2026 to the primary completion date, Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 40 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | Hong Kong | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.