The Effects of Bifidobacterium-based Probiotics in Reducing Blood Pressure in Middle-aged Chinese With Hypertension
NCT ID: NCT07206303
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE1
30 participants
INTERVENTIONAL
2025-12-31
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Probiotics on Primary Hypertension
NCT05095350
Effect of Probiotics on Blood Pressure Management
NCT03973710
Effect of 12-week Probiotic Supplementation on Bacterial and Viral Infections in Infants Aged 6 to 12 Months.
NCT01724203
Probiotic Influence on Obesity-Related Lipidemia
NCT06305650
Evaluation of Probiotics on Symptoms of Upper Respiratory Tract Infections
NCT00599430
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
30 recruited participants receiving commercially available probiotics supplements
30 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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* 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.
40 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The University of Hong Kong
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Gary Kui Kai LAU
Clinical Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gary KK Lau
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The University of Hong Kong
Hong Kong, , Hong Kong
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Bai B, Yang Y, Wang Q, Li M, Tian C, Liu Y, Aung LHH, Li PF, Yu T, Chu XM. NLRP3 inflammasome in endothelial dysfunction. Cell Death Dis. 2020 Sep 18;11(9):776. doi: 10.1038/s41419-020-02985-x.
Chumpitazi BP, Self MM, Czyzewski DI, Cejka S, Swank PR, Shulman RJ. Bristol Stool Form Scale reliability and agreement decreases when determining Rome III stool form designations. Neurogastroenterol Motil. 2016 Mar;28(3):443-8. doi: 10.1111/nmo.12738. Epub 2015 Dec 21.
Kolodziejczyk AA, Zheng D, Elinav E. Diet-microbiota interactions and personalized nutrition. Nat Rev Microbiol. 2019 Dec;17(12):742-753. doi: 10.1038/s41579-019-0256-8. Epub 2019 Sep 20.
Azzi A. Oxidative Stress: What Is It? Can It Be Measured? Where Is It Located? Can It Be Good or Bad? Can It Be Prevented? Can It Be Cured? Antioxidants (Basel). 2022 Jul 23;11(8):1431. doi: 10.3390/antiox11081431.
Okita Y, Nakamura H, Kouda K, Takahashi I, Takaoka T, Kimura M, Sugiura T. Effects of vegetable containing gamma-aminobutyric acid on the cardiac autonomic nervous system in healthy young people. J Physiol Anthropol. 2009;28(3):101-7. doi: 10.2114/jpa2.28.101.
Hayakawa K, Kimura M, Kamata K. Mechanism underlying gamma-aminobutyric acid-induced antihypertensive effect in spontaneously hypertensive rats. Eur J Pharmacol. 2002 Mar 1;438(1-2):107-13. doi: 10.1016/s0014-2999(02)01294-3.
Verhaar BJH, Prodan A, Nieuwdorp M, Muller M. Gut Microbiota in Hypertension and Atherosclerosis: A Review. Nutrients. 2020 Sep 29;12(10):2982. doi: 10.3390/nu12102982.
Zheng X, Qiu Y, Zhong W, Baxter S, Su M, Li Q, Xie G, Ore BM, Qiao S, Spencer MD, Zeisel SH, Zhou Z, Zhao A, Jia W. A targeted metabolomic protocol for short-chain fatty acids and branched-chain amino acids. Metabolomics. 2013 Aug 1;9(4):818-827. doi: 10.1007/s11306-013-0500-6.
Virwani PD, Qian G, Hsu MSS, Pijarnvanit TKKTS, Cheung CN, Chow YH, Tang LK, Tse YH, Xian JW, Lam SS, Lee CPI, Lo CCW, Liu RKC, Ho TL, Chow BY, Leung KS, Tsang HW, Lo EKK, Tung KTS, Chung SK, Yuen MF, Leung SY, Ip P, Hung IF, Louie JCY, El-Nezami H, Ho JWK, Lau KK. Sex Differences in Association Between Gut Microbiome and Essential Hypertension Based on Ambulatory Blood Pressure Monitoring. Hypertension. 2023 Jun;80(6):1331-1342. doi: 10.1161/HYPERTENSIONAHA.122.20752. Epub 2023 Apr 19.
Gerdts E, Sudano I, Brouwers S, Borghi C, Bruno RM, Ceconi C, Cornelissen V, Dievart F, Ferrini M, Kahan T, Lochen ML, Maas AHEM, Mahfoud F, Mihailidou AS, Moholdt T, Parati G, de Simone G. Sex differences in arterial hypertension. Eur Heart J. 2022 Dec 7;43(46):4777-4788. doi: 10.1093/eurheartj/ehac470.
Lau RI, Su Q, Lau ISF, Ching JYL, Wong MCS, Lau LHS, Tun HM, Mok CKP, Chau SWH, Tse YK, Cheung CP, Li MKT, Yeung GTY, Cheong PK, Chan FKL, Ng SC. A synbiotic preparation (SIM01) for post-acute COVID-19 syndrome in Hong Kong (RECOVERY): a randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2024 Mar;24(3):256-265. doi: 10.1016/S1473-3099(23)00685-0. Epub 2023 Dec 7.
Su Q, Liu Q, Zhang L, Xu Z, Liu C, Lu W, Ching JY, Li A, Mak JWY, Lui GCY, Ng SSS, Chow KM, Hui DS, Chan PK, Chan FKL, Ng SC. Antibiotics and probiotics impact gut antimicrobial resistance gene reservoir in COVID-19 patients. Gut Microbes. 2022 Jan-Dec;14(1):2128603. doi: 10.1080/19490976.2022.2128603.
Zhang L, Xu Z, Mak JWY, Chow KM, Lui G, Li TCM, Wong CK, Chan PKS, Ching JYL, Fujiwara Y, Chan FKL, Ng SC. Gut microbiota-derived synbiotic formula (SIM01) as a novel adjuvant therapy for COVID-19: An open-label pilot study. J Gastroenterol Hepatol. 2022 May;37(5):823-831. doi: 10.1111/jgh.15796. Epub 2022 Mar 2.
Chang BJ, Park SU, Jang YS, Ko SH, Joo NM, Kim SI, Kim CH, Chang DK. Effect of functional yogurt NY-YP901 in improving the trait of metabolic syndrome. Eur J Clin Nutr. 2011 Nov;65(11):1250-5. doi: 10.1038/ejcn.2011.115. Epub 2011 Jun 22.
Savard P, Lamarche B, Paradis ME, Thiboutot H, Laurin E, Roy D. Impact of Bifidobacterium animalis subsp. lactis BB-12 and, Lactobacillus acidophilus LA-5-containing yoghurt, on fecal bacterial counts of healthy adults. Int J Food Microbiol. 2011 Sep 1;149(1):50-7. doi: 10.1016/j.ijfoodmicro.2010.12.026. Epub 2011 Jan 15.
Agerholm-Larsen L, Raben A, Haulrik N, Hansen AS, Manders M, Astrup A. Effect of 8 week intake of probiotic milk products on risk factors for cardiovascular diseases. Eur J Clin Nutr. 2000 Apr;54(4):288-97. doi: 10.1038/sj.ejcn.1600937.
Usinger L, Ibsen H, Linneberg A, Azizi M, Flambard B, Jensen LT. Human in vivo study of the renin-angiotensin-aldosterone system and the sympathetic activity after 8 weeks daily intake of fermented milk. Clin Physiol Funct Imaging. 2010 Mar;30(2):162-8. doi: 10.1111/j.1475-097X.2009.00921.x. Epub 2010 Jan 26.
van der Zander K, Jakel M, Bianco V, Koning MM. Fermented lactotripeptides-containing milk lowers daytime blood pressure in high normal-to-mild hypertensive subjects. J Hum Hypertens. 2008 Nov;22(11):804-6. doi: 10.1038/jhh.2008.59. Epub 2008 Jun 5.
Sano J, Ohki K, Higuchi T, Aihara K, Mizuno S, Kajimoto O, Nakagawa S, Kajimoto Y, Nakamura Y. Effect of casein hydrolysate, prepared with protease derived from Aspergillus oryzae, on subjects with high-normal blood pressure or mild hypertension. J Med Food. 2005 Winter;8(4):423-30. doi: 10.1089/jmf.2005.8.423.
Jauhiainen T, Vapaatalo H, Poussa T, Kyronpalo S, Rasmussen M, Korpela R. Lactobacillus helveticus fermented milk lowers blood pressure in hypertensive subjects in 24-h ambulatory blood pressure measurement. Am J Hypertens. 2005 Dec;18(12 Pt 1):1600-5. doi: 10.1016/j.amjhyper.2005.06.006.
Aihara K, Kajimoto O, Hirata H, Takahashi R, Nakamura Y. Effect of powdered fermented milk with Lactobacillus helveticus on subjects with high-normal blood pressure or mild hypertension. J Am Coll Nutr. 2005 Aug;24(4):257-65. doi: 10.1080/07315724.2005.10719473.
Mizuno S, Matsuura K, Gotou T, Nishimura S, Kajimoto O, Yabune M, Kajimoto Y, Yamamoto N. Antihypertensive effect of casein hydrolysate in a placebo-controlled study in subjects with high-normal blood pressure and mild hypertension. Br J Nutr. 2005 Jul;94(1):84-91. doi: 10.1079/bjn20051422.
Hata Y, Yamamoto M, Ohni M, Nakajima K, Nakamura Y, Takano T. A placebo-controlled study of the effect of sour milk on blood pressure in hypertensive subjects. Am J Clin Nutr. 1996 Nov;64(5):767-71. doi: 10.1093/ajcn/64.5.767.
Tuomilehto J, Lindstrom J, Hyyrynen J, Korpela R, Karhunen ML, Mikkola L, Jauhiainen T, Seppo L, Nissinen A. Effect of ingesting sour milk fermented using Lactobacillus helveticus bacteria producing tripeptides on blood pressure in subjects with mild hypertension. J Hum Hypertens. 2004 Nov;18(11):795-802. doi: 10.1038/sj.jhh.1001745.
Inoue K, Shirai T, Ochiai H, Kasao M, Hayakawa K, Kimura M, Sansawa H. Blood-pressure-lowering effect of a novel fermented milk containing gamma-aminobutyric acid (GABA) in mild hypertensives. Eur J Clin Nutr. 2003 Mar;57(3):490-5. doi: 10.1038/sj.ejcn.1601555.
Wong MCS, Zhang L, Ching JYL, Mak JWY, Huang J, Wang S, Mok CKP, Wong A, Chiu OL, Fung YT, Cheong PK, Tun HM, Ng SC, Chan FKL. Effects of Gut Microbiome Modulation on Reducing Adverse Health Outcomes among Elderly and Diabetes Patients during the COVID-19 Pandemic: A Randomised, Double-Blind, Placebo-Controlled Trial (IMPACT Study). Nutrients. 2023 Apr 20;15(8):1982. doi: 10.3390/nu15081982.
Shimada M, Hasegawa T, Nishimura C, Kan H, Kanno T, Nakamura T, Matsubayashi T. Anti-hypertensive effect of gamma-aminobutyric acid (GABA)-rich Chlorella on high-normal blood pressure and borderline hypertension in placebo-controlled double blind study. Clin Exp Hypertens. 2009 Jun;31(4):342-54. doi: 10.1080/10641960902977908.
Ma P, Li T, Ji F, Wang H, Pang J. Effect of GABA on blood pressure and blood dynamics of anesthetic rats. Int J Clin Exp Med. 2015 Aug 15;8(8):14296-302. eCollection 2015.
Duranti S, Ruiz L, Lugli GA, Tames H, Milani C, Mancabelli L, Mancino W, Longhi G, Carnevali L, Sgoifo A, Margolles A, Ventura M, Ruas-Madiedo P, Turroni F. Bifidobacterium adolescentis as a key member of the human gut microbiota in the production of GABA. Sci Rep. 2020 Aug 24;10(1):14112. doi: 10.1038/s41598-020-70986-z.
Li Y, He L, Zhao Q, Bo T. Microbial and metabolic profiles of bronchopulmonary dysplasia and therapeutic effects of potential probiotics Limosilactobacillus reuteri and Bifidobacterium bifidum. J Appl Microbiol. 2022 Aug;133(2):908-921. doi: 10.1111/jam.15602. Epub 2022 May 16.
Lu W, Wang Y, Fang Z, Wang H, Zhu J, Zhai Q, Zhao J, Zhang H, Chen W. Bifidobacterium longum CCFM752 prevented hypertension and aortic lesion, improved antioxidative ability, and regulated the gut microbiome in spontaneously hypertensive rats. Food Funct. 2022 Jun 6;13(11):6373-6386. doi: 10.1039/d1fo04446j.
Averina OV, Kovtun AS, Mavletova DA, Ziganshin RH, Danilenko VN, Mihaylova D, Blazheva D, Slavchev A, Brazkova M, Ibrahim SA, Krastanov A. Oxidative Stress Response of Probiotic Strain Bifidobacterium longum subsp. longum GT15. Foods. 2023 Sep 7;12(18):3356. doi: 10.3390/foods12183356.
Fan L, Qi Y, Qu S, Chen X, Li A, Hendi M, Xu C, Wang L, Hou T, Si J, Chen S. B. adolescentis ameliorates chronic colitis by regulating Treg/Th2 response and gut microbiota remodeling. Gut Microbes. 2021 Jan-Dec;13(1):1-17. doi: 10.1080/19490976.2020.1826746.
Chen S, Chen L, Qi Y, Xu J, Ge Q, Fan Y, Chen D, Zhang Y, Wang L, Hou T, Yang X, Xi Y, Si J, Kang L, Wang L. Bifidobacterium adolescentis regulates catalase activity and host metabolism and improves healthspan and lifespan in multiple species. Nat Aging. 2021 Nov;1(11):991-1001. doi: 10.1038/s43587-021-00129-0. Epub 2021 Nov 16.
Sun HJ, Ren XS, Xiong XQ, Chen YZ, Zhao MX, Wang JJ, Zhou YB, Han Y, Chen Q, Li YH, Kang YM, Zhu GQ. NLRP3 inflammasome activation contributes to VSMC phenotypic transformation and proliferation in hypertension. Cell Death Dis. 2017 Oct 5;8(10):e3074. doi: 10.1038/cddis.2017.470.
Rodrigo R, Gonzalez J, Paoletto F. The role of oxidative stress in the pathophysiology of hypertension. Hypertens Res. 2011 Apr;34(4):431-40. doi: 10.1038/hr.2010.264. Epub 2011 Jan 13.
Montezano AC, Touyz RM. Oxidative stress, Noxs, and hypertension: experimental evidence and clinical controversies. Ann Med. 2012 Jun;44 Suppl 1:S2-16. doi: 10.3109/07853890.2011.653393.
Zhang Z, Zhao L, Zhou X, Meng X, Zhou X. Role of inflammation, immunity, and oxidative stress in hypertension: New insights and potential therapeutic targets. Front Immunol. 2023 Jan 10;13:1098725. doi: 10.3389/fimmu.2022.1098725. eCollection 2022.
Joseph TA, Pe'er I. An Introduction to Whole-Metagenome Shotgun Sequencing Studies. Methods Mol Biol. 2021;2243:107-122. doi: 10.1007/978-1-0716-1103-6_6.
Zhao TX, Zhang L, Zhou N, Sun DS, Xie JH, Xu SK. Long-term use of probiotics for the management of office and ambulatory blood pressure: A systematic review and meta-analysis of randomized, controlled trials. Food Sci Nutr. 2022 Sep 20;11(1):101-113. doi: 10.1002/fsn3.3069. eCollection 2023 Jan.
Khalesi S, Sun J, Buys N, Jayasinghe R. Effect of probiotics on blood pressure: a systematic review and meta-analysis of randomized, controlled trials. Hypertension. 2014 Oct;64(4):897-903. doi: 10.1161/HYPERTENSIONAHA.114.03469. Epub 2014 Jul 21.
Dong JY, Szeto IM, Makinen K, Gao Q, Wang J, Qin LQ, Zhao Y. Effect of probiotic fermented milk on blood pressure: a meta-analysis of randomised controlled trials. Br J Nutr. 2013 Oct;110(7):1188-94. doi: 10.1017/S0007114513001712. Epub 2013 Jul 3.
Li J, Zhao F, Wang Y, Chen J, Tao J, Tian G, Wu S, Liu W, Cui Q, Geng B, Zhang W, Weldon R, Auguste K, Yang L, Liu X, Chen L, Yang X, Zhu B, Cai J. Gut microbiota dysbiosis contributes to the development of hypertension. Microbiome. 2017 Feb 1;5(1):14. doi: 10.1186/s40168-016-0222-x.
Muralitharan RR, Jama HA, Xie L, Peh A, Snelson M, Marques FZ. Microbial Peer Pressure: The Role of the Gut Microbiota in Hypertension and Its Complications. Hypertension. 2020 Dec;76(6):1674-1687. doi: 10.1161/HYPERTENSIONAHA.120.14473. Epub 2020 Oct 5.
Hamrahian SM, Maarouf OH, Fulop T. A Critical Review of Medication Adherence in Hypertension: Barriers and Facilitators Clinicians Should Consider. Patient Prefer Adherence. 2022 Oct 7;16:2749-2757. doi: 10.2147/PPA.S368784. eCollection 2022.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GL202401
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.