Effect of Probiotics on Primary Hypertension

NCT05095350 | Completed Early Phase 1

• 1 other identifier: PROB(2017-BJJW)
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Hypertension

Keywords

Hypertension; Microbiome; Probiotics; Treatment

Outcome Measures

Primary Outcomes (1)

• Change in Office Systolic Blood Pressure (SBP)

  Change in Office Systolic Blood Pressure (SBP)

  From baseline to day 56

Secondary Outcomes (17)

• Change in Office SBP

  Baseline, Day28, Day 56, Day 84

• Change in Office Diastolic Blood Pressure (DBP)

  Baseline, Day28, Day 56, Day 84

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

  Baseline, Day28, Day 56, Day 84

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

  Baseline, Day28, Day 56, Day 84

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

  Baseline, Day28, Day 56, Day 84

Study Arms (2)

Probiotic powder

EXPERIMENTAL

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 powder

PLACEBO COMPARATOR

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

Probiotic powder BIOLOGICAL

Probiotic powder containing 10 strains from Lactobacillus and Bifidobacterium genus.

Probiotic powder

Placebo powder BIOLOGICAL

Placebo powder containing maltodextrin and no probiotics.

Placebo powder

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead
• Beijing Municipal Education Commission: collaborator

Study Sites (6)

Fu Wai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

Location

Longgang District People's Hospital of Shenzhen

Shenzhen, Guangdong, 518000, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430000, China

Location

The Second Affiliated Hospital of Baotou Medical Collage

Baotou, Neimenggu, 014000, China

Location

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610000, China

Location

Related Publications (4)

• 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.

  PMID: 28143587 BACKGROUND

• 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.

  PMID: 29143823 BACKGROUND

• 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.

  PMID: 31953983 BACKGROUND

• 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.

  PMID: 25047574 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• JUN CAI

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of Hypertension Center

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 27, 2021
• Study Start: December 5, 2021
• Primary Completion: June 2, 2023
• Study Completion: June 2, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-01

Locations

CN (6)