NCT07206303

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-term Feasibility Pilot Study

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

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 10 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.

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 according to ACC/AHA guidelines (SBP ≥130 mm Hg) after 10 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. The four independent but interrelated objectives of this study include: 1. To investigate if oral administration of Bifidobacterium-based probiotic intervention will reduce clinic SBP and DBP from baseline to the end of treatment. 2. To observe changes in 24-hour mean, daytime and nighttime SBP and DBP assessed by 24-hour ambulatory BP monitoring from baseline to the end of treatment. 3. To evaluate the impact of probiotics intervention on gut microbiome (GM) composition and functions characterized by shotgun metagenomic sequencing of stool. 4. To explore potential underlying mechanisms of Bifidobacterium-based probiotics on lowering BP by assessing serum proinflammatory and oxidative stress markers and circulating GM-derived metabolites, including SCFAs and GABA. Additionally, the investigators will conduct sex-stratified analysis to explore potential sex differences in BP lowering response to the intervention since sex-linked differences in the initiation and progression of hypertension pathology are well-established, and the investigators recently reported that association between GM and hypertension is also sex-linked.

Conditions

• Hypertension

Interventions

Type	Name	Description
BIOLOGICAL	Bifidobacterium probiotics supplementation	The 10-week research period consists of one prescreening and baseline visit (week -1) and two follow-up visits (week 5 (±7days) and week 10 (±7days)). The participants will be instructed to fast overnight before their visits in the mornings of week -1 and week 10. 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 5 and 10. 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 10 weeks. They will be instructed to mix the probiotics with water and consume with their dinner.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-10-03
• Last updated: 2025-11-19

Locations

1 site across 1 country: Hong Kong