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HypertensionEarly Phase 1NCT05095350

Effect of Probiotics on Primary Hypertension

A Early Phase 1 study testing Probiotic powder in people with Hypertension, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 6 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Hypertension
What is being tested?
Probiotic powder
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
115 participants
Where
6 sitesChina
Study dates
5 Dec 2021to 2 Jun 2023
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age 18~60 years.
  • 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)".
  • Patients with informed consent after thorough explanation.

Who cannot join

  • Antibiotics or probiotics usage within the last 2 weeks.
  • Participants of other clinical trials currently or within last 3 months.
  • Antihypertensive medications usage currently or within last 2 weeks.
  • Diagnosed secondary hypertension
  • History of diabetes mellitus.
  • History of peripheral atherosclerosis.
Show all 19Show fewer
  • 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]).
  • History of stroke (not including lacunar infarction and transient ischemic attack [TIA]).
  • History of coronary heart disease.
  • Sustained atrial fibrillation or arrhythmias at recruitment disturbing the electronic BP measurement.
  • NYHA class III-IV heart failure; Hospitalization for chronic heart failure exacerbation within last 6 months.
  • Severe valvular diseases; Potential for surgery or percutaneous valve replacement within the study period.
  • Dilated cardiomyopathy; Hypertrophic cardiomyopathy; Rheumatic heart disease; Congenital heart disease.
  • Other severe diseases influencing the entry or survival of participants, such as malignant tumor or acquired immune deficiency syndrome.
  • Cognitive impairment or severe neuropsychiatric comorbidities who are incapable of providing their own informed consent.
  • Participants preparing for or under pregnancy and/or lactation.
  • With special diet habits, such as vegetarians.
  • Active gastritis or enteritis; gastrointestinal ulcers or bleeding; post-gastrointestinal surgery, such as intestinal excision.
  • Other conditions inappropriate for recruitment according to the investigators.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • The Second Affiliated Hospital of Baotou Medical Collage

    Baotou, Neimenggu, 014000

  • Fu Wai Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100037

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610000

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200000

  • Longgang District People's Hospital of Shenzhen

    Shenzhen, Guangdong, 518000

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430000

Other trials in China

About this study

Official title: Effect of Probiotics on Grade 1 Primary Hypertension and Prehypertension and the Underlying Mechanism: a Randomized Controlled Trial

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.

Conditions
Hypertension
Being tested
Probiotic powder, Placebo powder
Keywords
Hypertension, Microbiome, Probiotics, Treatment
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Probiotic powderBiological

    Probiotic powder containing 10 strains from Lactobacillus and Bifidobacterium genus.

  • Placebo powderBiological

    Placebo powder containing maltodextrin and no probiotics.

Study groups in NCT05095350
Study groupRoleWhat they receive
Probiotic powderExperimentalThe probiotic powder contains 10 strains from Lactobacillus and Bifidobacterium genus. Participants will orally take two sachets daily and last for 8 weeks.
Receives: Biological: Probiotic powder
Placebo powderPlacebo comparatorThe placebo powder consists of maltodextrin and contains no probiotics. Participants will orally take two sachets daily and last for 8 weeks.
Receives: Biological: Placebo powder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Office Systolic Blood Pressure (SBP)

    Change in Office Systolic Blood Pressure (SBP)

    Measured: From baseline to day 56

Secondary outcomes (17)

  1. Change in Office SBP

    Change in Office SBP

    Measured: Baseline, Day28, Day 56, Day 84

  2. Change in Office Diastolic Blood Pressure (DBP)

    Change in Office Diastolic Blood Pressure (DBP)

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: 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

    Measured: Baseline, Day28, Day 56, Day 84

  14. Change in Fasting Blood Glucose Level

    Change in Fasting Blood Glucose Level

    Measured: 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)

    Measured: Baseline, Day 56

  16. Change in Blood Uric Acid

    Change in Blood Uric Acid

    Measured: Baseline, Day 56

  17. Change in Body Mass Index

    Change in Body Mass Index

    Measured: Baseline, Day 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2021
  2. Study start5 Dec 2021
  3. Primary completion2 Jun 2023
  4. Study completion2 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05095350
Sponsor's protocol ID
PROB(2017-BJJW)
Status last verified
Jan 2023
First submitted
4 Oct 2021
Last updated
5 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Probiotic powder in people with Hypertension, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Office Systolic Blood Pressure (SBP) (time frame: From baseline to day 56). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05095350, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.

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