NCT03906578

Brief Summary

High blood pressure is a major risk factor for cardiovascular events, including stroke, heart and kidney failure. Typical anti-hypertensive drugs target vessels, the kidneys or the heart. Here we propose a randomized, placebo-controlled study to test the blood pressure-lowering effect of a probiotic in 110 patients with grade 1 hypertension. In addition, we will investigate glucose variability, fecal bacterial metabolome, peripheral blood effector T cell frequencies (%) and health-related quality of life.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

September 2, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

5 years

First QC Date

April 5, 2019

Last Update Submit

July 8, 2024

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Nocturnal systolic blood pressure

    Measured by 24h ABPM (mmHg)

    After 8 weeks compared to placebo and adjusted to baseline

Secondary Outcomes (17)

  • Nocturnal diastolic blood pressure

    After 8 weeks compared to placebo and adjusted to baseline

  • 24h systolic blood pressure

    After 8 weeks compared to placebo and adjusted to baseline

  • 24h diastolic blood pressure

    After 8 weeks compared to placebo and adjusted to baseline

  • Office systolic blood pressure

    After 8 weeks compared to placebo and adjusted to baseline

  • Office diastolic blood pressure

    After 8 weeks compared to placebo and adjusted to baseline

  • +12 more secondary outcomes

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

Two sachets Vivomixx® containing 8 strains of life bacteria (9 x 10\^11 CFU) in the evening for 8 weeks

Dietary Supplement: Vivomixx®

Placebo

PLACEBO COMPARATOR

Two sachets placebo in the evening for 8 weeks

Other: Placebo

Interventions

Vivomixx®DIETARY_SUPPLEMENT

Microbiotic food supplement with L. paracasei, L. plantarum, L. acidophilus, L. delbrueckii, B. longum, B. infantis, B. breve, S. thermophilus

Probiotic
PlaceboOTHER

Placebo with similar appearance to probiotic

Placebo

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and postmenopausal women
  • Treated or untreated hypertension (resting office blood pressure 130-159/80-99 mmHg)
  • BMI 18.5 - 34.9 kg/m\^2

You may not qualify if:

  • Secondary causes of hypertension
  • Known target organ damage
  • years cardiovascular risk score of \>20%
  • Diabetes
  • Established cardiovascular or renal disease
  • Other serious diseases
  • Recent use of antibiotics
  • Specialized diets, e.g. use of probiotics
  • Comments:
  • Age was changed from 50-75 to 50-80 years
  • Resting blood pressure was changed from 140-159/90-99 to 130-159/80-99 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Experimental and Clinical Research Center

Berlin, 13125, Germany

Location

Related Publications (1)

  • Mahler A, Wilck N, Rauch G, Dechend R, Muller DN. Effect of a probiotic on blood pressure in grade 1 hypertension (HYPRO): protocol of a randomized controlled study. Trials. 2020 Dec 29;21(1):1032. doi: 10.1186/s13063-020-04973-0.

    PMID: 33375942BACKGROUND

Related Links

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Anja Mähler, PhD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

  • Dominik N. Müller, PhD

    Max Delbruck Center (MDC)

    PRINCIPAL INVESTIGATOR

  • Ralf Dechend, MD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 5, 2019

First Posted

April 8, 2019

Study Start

September 2, 2019

Primary Completion

September 1, 2024

Study Completion

September 1, 2025

Last Updated

July 9, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 9 months and ending 36 months following article publication.
Access Criteria
Researchers who provide a methodologically sound proposal.

Locations

DE(1)