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
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COMPLETED
EARLY_PHASE1
115 participants
INTERVENTIONAL
2021-12-05
2023-06-02
Brief Summary
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Detailed Description
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Objective: To explore the effect, safety, and underlying mechanisms of the combination of probiotics on grade 1 primary hypertension and prehypertension.
Study Design: A multicenter, randomized, double-blinded, placebo-controlled pilot study.
Data quality control and statistical analysis: The investigators have invited professional statistic analysts to assist in analyzing data and a third party to supervise data quality.
Ethics: The Ethics Committee of Fuwai Hospital approved this study. Informed consent before patient enrollment is required.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Probiotic powder
The probiotic powder contains 10 strains from Lactobacillus and Bifidobacterium genus. Participants will orally take two sachets daily and last for 8 weeks.
Probiotic powder
Probiotic powder containing 10 strains from Lactobacillus and Bifidobacterium genus.
Placebo powder
The placebo powder consists of maltodextrin and contains no probiotics. Participants will orally take two sachets daily and last for 8 weeks.
Placebo powder
Placebo powder containing maltodextrin and no probiotics.
Interventions
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Probiotic powder
Probiotic powder containing 10 strains from Lactobacillus and Bifidobacterium genus.
Placebo powder
Placebo powder containing maltodextrin and no probiotics.
Eligibility Criteria
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Inclusion Criteria
2. Grade 1 hypertension and part of prehypertension (initial diagnosis or free from antihypertensive drugs within 2 weeks): 130 mmHg ≤ Average office SBP \< 160 mmHg, and/or 85 mmHg ≤ Average office DBP \< 100 mmHg, according to the "2018 Chinese Guidelines for Prevention and Treatment of Hypertension" and "National guideline for hypertension management in China (2019)".
3. Patients with informed consent after thorough explanation.
Exclusion Criteria
2. Participants of other clinical trials currently or within last 3 months.
3. Antihypertensive medications usage currently or within last 2 weeks.
4. Diagnosed secondary hypertension
5. History of diabetes mellitus.
6. History of peripheral atherosclerosis.
7. Severe hepatic or renal diseases (ALT \>3 times the upper limit of normal value, or end-stage renal disease on dialysis or eGFR \<30 mL/min/1.73 m2, or serum creatinine \>2.5 mg/dl \[\>221 μmol/L\]).
8. History of stroke (not including lacunar infarction and transient ischemic attack \[TIA\]).
9. History of coronary heart disease.
10. Sustained atrial fibrillation or arrhythmias at recruitment disturbing the electronic BP measurement.
11. NYHA class III-IV heart failure; Hospitalization for chronic heart failure exacerbation within last 6 months.
12. Severe valvular diseases; Potential for surgery or percutaneous valve replacement within the study period.
13. Dilated cardiomyopathy; Hypertrophic cardiomyopathy; Rheumatic heart disease; Congenital heart disease.
14. Other severe diseases influencing the entry or survival of participants, such as malignant tumor or acquired immune deficiency syndrome.
15. Cognitive impairment or severe neuropsychiatric comorbidities who are incapable of providing their own informed consent.
16. Participants preparing for or under pregnancy and/or lactation.
17. With special diet habits, such as vegetarians.
18. Active gastritis or enteritis; gastrointestinal ulcers or bleeding; post-gastrointestinal surgery, such as intestinal excision.
19. Other conditions inappropriate for recruitment according to the investigators.
18 Years
60 Years
ALL
No
Sponsors
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Beijing Municipal Education Commission
UNKNOWN
Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
Responsible Party
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Jun Cai
Professor, Director of Hypertension Center
Principal Investigators
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JUN CAI
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences, Fuwai Hospital
Locations
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Fu Wai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Longgang District People's Hospital of Shenzhen
Shenzhen, Guangdong, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
The Second Affiliated Hospital of Baotou Medical Collage
Baotou, Neimenggu, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Countries
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References
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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.
Wilck N, Matus MG, Kearney SM, Olesen SW, Forslund K, Bartolomaeus H, Haase S, Mahler A, Balogh A, Marko L, Vvedenskaya O, Kleiner FH, Tsvetkov D, Klug L, Costea PI, Sunagawa S, Maier L, Rakova N, Schatz V, Neubert P, Fratzer C, Krannich A, Gollasch M, Grohme DA, Corte-Real BF, Gerlach RG, Basic M, Typas A, Wu C, Titze JM, Jantsch J, Boschmann M, Dechend R, Kleinewietfeld M, Kempa S, Bork P, Linker RA, Alm EJ, Muller DN. Salt-responsive gut commensal modulates TH17 axis and disease. Nature. 2017 Nov 30;551(7682):585-589. doi: 10.1038/nature24628. Epub 2017 Nov 15.
Robles-Vera I, Toral M, de la Visitacion N, Sanchez M, Gomez-Guzman M, Romero M, Yang T, Izquierdo-Garcia JL, Jimenez R, Ruiz-Cabello J, Guerra-Hernandez E, Raizada MK, Perez-Vizcaino F, Duarte J. Probiotics Prevent Dysbiosis and the Rise in Blood Pressure in Genetic Hypertension: Role of Short-Chain Fatty Acids. Mol Nutr Food Res. 2020 Mar;64(6):e1900616. doi: 10.1002/mnfr.201900616. Epub 2020 Feb 6.
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.
Other Identifiers
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PROB(2017-BJJW)
Identifier Type: -
Identifier Source: org_study_id