The Effects of Bifidobacterium-based Probiotics in Reducing Blood Pressure in Middle-aged Chinese With Hypertension
1 other identifier
interventional
30
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 hypertension
Started May 2026
Typical duration for phase_1 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2025
CompletedFirst Posted
Study publicly available on registry
October 3, 2025
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
May 11, 2026
May 1, 2026
1 year
September 25, 2025
May 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean seated clinic systolic blood pressure (SBP)
Three consecutive BP measurements will be assessed using an automatic BP monitor, Microlife BP A200 AFIB (Microlife, Taiwan). Prior to taking BP measurements, participants will be instructed to sit and rest for at least five minutes. Participants will be advised to maintain an upright posture, with their arms positioned at heart level and palms facing upwards. Additionally, they will be advised to refrain from speaking during process. The average of three BP measurements will be taken to minimize random error.
During clinical visits at: - Baseline (a week prior to treatment), - Week 4, 8 of treatment - Week 12 of treatment (end of treatment)
Secondary Outcomes (6)
Mean seated clinic diastolic blood pressure (DBP)
During clinical visits at: - Baseline (a week prior to treatment), - Week 4, 8 of treatment - Week 12 of treatment (end of treatment)
Mean 24-hour ambulatory SBP
During clinical visits at: - Baseline (a week prior to treatment), - Week 12 of treatment (end of treatment)
Gut microbiome composition and functions
During clinical visits at: - Baseline (a week prior to treatment), - Week 12 of treatment (end of treatment)
Plasma levels of gut microbiome-derived metabolites, short-chain fatty acids (SCFA) and gamma amino butyric acids (GABA)
During clinical visits at: - Baseline (a week prior to treatment), - Week 12 of treatment (end of treatment)
Serum levels of proinflammatory and oxidative stress markers
During clinical visits at: - Baseline (a week prior to treatment), - Week 12 of treatment (end of treatment)
- +1 more secondary outcomes
Study Arms (1)
30 recruited participants receiving commercially available probiotics supplements
EXPERIMENTAL30 community-dwelling, middle-aged Hong Kong Chinese (15 men and 15 women) with hypertension according to ACC/AHA guidelines (SBP ≥130 mm Hg) who are not taking antihypertensive agents and are free of symptomatic cardiovascular or cerebrovascular diseases will be recruited in this study. Participants will be recruited via our outreach promotion program or social media and recruitment posters will be distributed physically or posted online.
Interventions
The 12-week research period consists of one prescreening and baseline visit (week -1) and three follow-up visits (week 4 (±7days), week 8 (±7days) and week 12 (±7days)). The participants will be instructed to fast overnight before their visits in the mornings of week -1 and week 12. The measurements will include documentation of personal and demographic information; three consecutive clinic BP readings; 24-hour ambulatory BP monitoring; a 3-day diet diary to monitor consistency of dietary intake; collection of fecal samples and blood samples for analysis of GM composition and biomarkers, respectively at baseline, and week 8 and 12. Only participants who are able to provide all the required data and samples within 7 days after the prescreening and baseline visit (week -1) will be eligible to receive the Bifidobacterium supplementation with 20 billion cfu once a day for 12 weeks. They will be instructed to mix the probiotics with water and consume with their dinner.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 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 of the components of SIM01probiotics supplement.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Hong Kong
Hong Kong, Hong Kong
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PMID: 36237983BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gary KK Lau
The University of Hong Kong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Associate Professor
Study Record Dates
First Submitted
September 25, 2025
First Posted
October 3, 2025
Study Start
May 1, 2026
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
May 11, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share