Status:
NOT_YET_RECRUITING
The Effects of Bifidobacterium-based Probiotics in Reducing Blood Pressure in Middle-aged Chinese With Hypertension
Lead Sponsor:
The University of Hong Kong
Conditions:
Hypertension
Eligibility:
All Genders
40-65 years
Phase:
PHASE1
Brief 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...
Detailed 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...
Eligibility Criteria
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
- 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 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 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.
- Known allergies to any components of commercially-available probiotic supplements.
- Women who are pregnant, or intending to become pregnant, or lactation.
- Intending to participate or have participated in a clinical or nutritional intervention study in the last 30 days before study enrolment.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07206303
Start Date
December 1 2025
End Date
December 1 2026
Last Update
November 19 2025
Active Locations (1)
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1
The University of Hong Kong
Hong Kong, Hong Kong