Effects of a Probiotic in Hypertension

NCT ID: NCT03906578

Last Updated: 2024-07-09

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-02

Study Completion Date

2025-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Probiotic

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

Group Type ACTIVE_COMPARATOR

Vivomixx®

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Two sachets placebo in the evening for 8 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo with similar appearance to probiotic

Interventions

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Vivomixx®

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo with similar appearance to probiotic

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Exclusion Criteria

* Secondary causes of hypertension
* Known target organ damage
* 10 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:
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Kristin Kraeker

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anja Mähler, PhD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Dominik N. Müller, PhD

Role: PRINCIPAL_INVESTIGATOR

Max Delbruck Center (MDC)

Ralf Dechend, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Experimental and Clinical Research Center

Berlin, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 33375942 (View on PubMed)

Related Links

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Other Identifiers

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HYPRO

Identifier Type: -

Identifier Source: org_study_id

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