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CompletedNCT05095350Updated Dec 5, 2023

Effect of Probiotics on Primary Hypertension

An Early Phase 1 interventional study of Probiotic powder and Placebo powder in Hypertension, sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Completed at 6 sites in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-12-05.

Sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
115
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

Gut microbiota was found to play a causal role in the pathogenesis of hypertension. Probiotics were shown to have a potential anti-hypertensive effect in human/rodent studies. This study aims to explore the effect, safety, and underlying mechanisms of the combination of probiotics, containing 10 strains from Lactobacillus and Bifidobacterium, on hypertension, compared with placebo.

Read the detailed description

Background: Primary hypertension is the leading risk factor of cardiovascular diseases and all-cause mortality, and contributes to severe global health burden. Emerging evidence has shown a close association between gut microbiota and hypertension. Fecal transplantation from hypertensive patients/animals to germ-free mice caused elevation of blood pressure, indicating a causal role of gut dysbiosis in hypertension. Probiotics were found to have a potential anti-hypertensive effect in both human and rodent studies. Based on the investigators' previous findings of metagenomics analysis of hypertensive, prehypertensive patients and healthy control, hypertensive and prehypertensive patients were lack of probiotics. Therefore, the investigators developed this study to explore the effect, safety, and underlying mechanisms of the combination of probiotics, containing 10 strains from Lactobacillus and Bifidobacterium, on hypertension, compared with placebo.

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.

02

Conditions studied

  • Hypertension

Keywords

  • Hypertension
  • Microbiome
  • Probiotics
  • Treatment
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 115 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital is the lead sponsor of 141 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 18\~60 years.
  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

Exclusion Criteria:

  1. Antibiotics or probiotics usage within the last 2 weeks.
  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.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
115 participants (actual)

Study arms

  • Experimental
    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.

    Biological: Probiotic powder

  • Placebo comparator
    Placebo powder

    The placebo powder consists of maltodextrin and contains no probiotics. Participants will orally take two sachets daily and last for 8 weeks.

    Biological: Placebo powder

Interventions

  • BiologicalProbiotic powder

    Probiotic powder containing 10 strains from Lactobacillus and Bifidobacterium genus.

  • BiologicalPlacebo powder

    Placebo powder containing maltodextrin and no probiotics.

06

What researchers measure

Primary outcomes

  1. Change in Office Systolic Blood Pressure (SBP)

    Change in Office Systolic Blood Pressure (SBP)

    Time frame: From baseline to day 56

Secondary outcomes

  1. Change in Office SBP

    Change in Office SBP

    Time frame: Baseline, Day28, Day 56, Day 84

  2. Change in Office Diastolic Blood Pressure (DBP)

    Change in Office Diastolic Blood Pressure (DBP)

    Time frame: Baseline, Day28, Day 56, Day 84

  3. Change in average SBP via 24-hour Ambulatory BP Monitoring

    Change in average SBP via 24-hour Ambulatory BP Monitoring

    Time frame: Baseline, Day28, Day 56, Day 84

  4. Change in average DBP via 24-hour Ambulatory BP Monitoring

    Change in average DBP via 24-hour Ambulatory BP Monitoring

    Time frame: Baseline, Day28, Day 56, Day 84

  5. Change in daytime average SBP via 24-hour Ambulatory BP Monitoring

    Change in daytime average SBP via 24-hour Ambulatory BP Monitoring

    Time frame: Baseline, Day28, Day 56, Day 84

  6. Change in daytime average DBP via 24-hour Ambulatory BP Monitoring

    Change in daytime average DBP via 24-hour Ambulatory BP Monitoring

    Time frame: Baseline, Day28, Day 56, Day 84

  7. Change in nightime average SBP via 24-hour Ambulatory BP Monitoring

    Change in nightime average SBP via 24-hour Ambulatory BP Monitoring

    Time frame: Baseline, Day28, Day 56, Day 84

  8. Change in nightime average DBP via 24-hour Ambulatory BP Monitoring

    Change in nightime average DBP via 24-hour Ambulatory BP Monitoring

    Time frame: Baseline, Day28, Day 56, Day 84

  9. Number of Participants with Adverse Events (AEs) as a Measure of Safety

    Number of Participants with Adverse Events (AEs) as a Measure of Safety

    Time frame: Baseline, Day28, Day 56, Day 84

  10. Changes in Intestinal Microbiota Composition Pre- and Post-intervention via Metagenomic Analysis

    Intestinal microbiota composition is obtained through sequencing of DNAs from feces samples and bioinformatic analysis. Changes in the intestinal microbiota composition before and after intervention (probiotics or placebo) is defined as a secondary outcome. This is stratified by: 1. Randomization (probiotics or placebo); 2. Changes in office SBP.

    Time frame: Baseline, Day28, Day 56, Day 84

  11. Changes in Intestinal Microbiota Function Pre- and Post-intervention via Metagenomic Analysis

    Intestinal microbiota function is obtained through sequencing of DNAs from feces samples and bioinformatic analysis according to functions related to detected genes. Changes in the intestinal microbiota function before and after intervention (probiotics or placebo) is defined as a secondary outcome. This is stratified by: 1. Randomization (probiotics or placebo); 2. Changes in office SBP.

    Time frame: Baseline, Day28, Day 56, Day 84

  12. Changes in Intestinal Metabolite Composition Pre- and Post-intervention via Metabolomic Analysis

    Metabolomics analysis is a quantitative analysis of all metabolites in the sample. Metabolites in feces are detected using liquid or gas chromatography combined with mass spectrometry, and the composition and abundance of each metabolite are obtained. Changes in the intestinal metabolite composition before and after intervention (probiotics or placebo) is defined as a secondary outcome. This is stratified by: 1. Randomization (probiotics or placebo); 2. Changes in office SBP. Randomisation Change in Office SBP

    Time frame: Baseline, Day28, Day 56, Day 84

  13. Changes in Serum Metabolite Composition Pre- and Post-intervention via Metabolomic Analysis

    Metabolomics analysis is a quantitative analysis of all metabolites in the sample. Metabolites in serum are detected using liquid or gas chromatography combined with mass spectrometry, and the composition and abundance of each metabolite are obtained. Changes in the serum metabolite composition before and after intervention (probiotics or placebo) is defined as a secondary outcome. This is stratified by: 1. Randomization (probiotics or placebo); 2. Changes in office SBP. Randomisation Change in Office SBP

    Time frame: Baseline, Day28, Day 56, Day 84

  14. Change in Fasting Blood Glucose Level

    Change in Fasting Blood Glucose Level

    Time frame: Baseline, Day 56

  15. Change in Blood Lipid Level (Total Cholesterol, Total Triglyceride, Low Density Lipoprotein Cholesterol, High Density Lipoprotein Cholesterol)

    Change in Blood Lipid Level (Total Cholesterol, Total Triglyceride, Low Density Lipoprotein Cholesterol, High Density Lipoprotein Cholesterol)

    Time frame: Baseline, Day 56

  16. Change in Blood Uric Acid

    Change in Blood Uric Acid

    Time frame: Baseline, Day 56

  17. Change in Body Mass Index

    Change in Body Mass Index

    Time frame: Baseline, Day 56

07

Study locations

6 sites
  • Fu Wai Hospital, Chinese Academy of Medical Sciences
    Beijing, Beijing 100037, China
  • Longgang District People's Hospital of Shenzhen
    Shenzhen, Guangdong 518000, China
  • Renmin Hospital of Wuhan University
    Wuhan, Hubei 430000, China
  • The Second Affiliated Hospital of Baotou Medical Collage
    Baotou, Neimenggu 014000, China
  • Renji Hospital, Shanghai Jiaotong University School of Medicine
    Shanghai, Shanghai 200000, China
  • Sichuan Provincial People's Hospital
    Chengdu, Sichuan 610000, China
08

References and documents

Publications

  • 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. PubMed 28143587 ↗
  • 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. PubMed 29143823 ↗
  • 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. PubMed 31953983 ↗
  • 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. PubMed 25047574 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05095350
Lead sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborators
Beijing Municipal Education Commission
Responsible party
Jun Cai (Professor, Director of Hypertension Center, Chinese Academy of Medical Sciences, Fuwai Hospital) — Principal investigator
First posted
Oct 27, 2021
Start date
Dec 5, 2021
Primary completion
Jun 2, 2023
Completion
Jun 2, 2023
Last update
Dec 5, 2023

Study contacts

JUN CAI
principal investigator · Chinese Academy of Medical Sciences, Fuwai Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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