Active not recruitingNAINTERVENTIONAL

Effects of a Probiotic in Hypertension

This study is investigating if a probiotic supplement, Vivomixx®, can help reduce high blood pressure. High blood pressure is a common condition that increases the risk of heart attacks, strokes, and kidney problems. While medicines often help by working on blood vessels, kidneys, or the heart, this research aims to see if beneficial bacteria could be another way to manage it. We're testing this in 110 people who have mild high blood pressure. Besides checking blood pressure, we'll also look at how blood sugar levels change, the types of bacteria in their gut, certain immune cells, and how their quality of life is affected. This helps us understand the full impact of the probiotic.

At a glance

Status

Active not recruiting

Phase

Sponsor

Charite University, Berlin, Germany

Enrolment target

Start

02 Sep 2019

Estimated completion

01 Sep 2025

Hypertension

What is this study about?

You might have heard of 'good bacteria' or probiotics that can be found in some yoghurts or supplements. This research study is trying to understand if a specific probiotic supplement, called Vivomixx®, could help people with high blood pressure. High blood pressure is a widespread health issue that, if left untreated, can put a lot of strain on your heart, brain, and kidneys over time, potentially leading to serious conditions like heart attacks, strokes, or kidney failure. It's a key factor in many health problems.

Currently, most medicines for high blood pressure work by affecting your blood vessels, kidneys, or heart to bring your blood pressure down. This study is exploring a different approach – using a probiotic. We want to see if introducing these beneficial bacteria into your gut can have a positive effect on your blood pressure. We also hope to learn more about how the probiotic might work, for example, by looking at how it affects your gut bacteria, your blood sugar levels, or even your immune system.

By taking part, you would help doctors and scientists understand if probiotics could become another useful tool in managing high blood pressure, potentially offering a new way to help people stay healthier. The study will carefully compare Vivomixx® to a 'dummy' treatment (placebo) to ensure we can clearly see any effects.

Key takeaways

The study is testing if a probiotic can help lower blood pressure.
It involves men and postmenopausal women aged 50-80 with mild high blood pressure.
Participants will receive either the probiotic or a dummy pill.
The research aims to find new ways to manage high blood pressure.
Your health will be monitored closely throughout the study.

Who may be eligible?

To join this study, we are looking for men and women who have gone through menopause. You need to be between 50 and 80 years old and have mild high blood pressure, which means your top blood pressure reading is between 130 and 159, and your bottom reading is between 80 and 99. You can have been diagnosed with high blood pressure already, or this might be a new diagnosis for you. Your weight should also be within a healthy range for your height – not too underweight and not severely overweight.

There are certain reasons why you might not be able to join. For example, if your high blood pressure is caused by another condition (like a kidney problem), or if you already have damage to your organs because of high blood pressure, then this study might not be suitable. We also can't include you if you've been diagnosed with diabetes, or if you've already had a heart attack, stroke, or severe kidney disease. If you've recently taken antibiotics or regularly use special diets or other probiotics, you won't be able to participate either.

The researchers have recently made it easier for more people to join by slightly changing the age range and the blood pressure numbers they are looking for, so don't hesitate to check if you think you might be suitable.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 50 and 80 years old?
Are you a man, or a woman who has gone through menopause?
Do you have mild high blood pressure (readings between 130-159 for the top number and 80-99 for the bottom number)?
Have you *not* had a recent course of antibiotics?
Do you *not* have diabetes, established heart, or kidney disease?
Do you *not* regularly take other probiotic supplements or specialised diets?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you'll be given either the probiotic supplement Vivomixx® or a dummy pill (placebo) to take. You won't know which one you're receiving, and neither will the study team, to make sure the results are fair. You'll have several visits to the clinic where your blood pressure will be measured, and you'll have some blood tests and provide stool samples. We'll also ask you questions about your general health and how you're feeling. The study will last for a set period, and we'll let you know the exact duration during the initial screening. You'll need to commit to attending all scheduled appointments to help us get accurate and complete information.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. A potential benefit of this study is that the probiotic might help lower your blood pressure, which could improve your health. You would also receive careful medical monitoring throughout the study. However, there's no guarantee that you will personally benefit, especially if you receive the placebo. Possible risks are generally mild, like potential stomach upset from the probiotic, but we will discuss all known side effects with you in detail. You are free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

Experimental and Clinical Research Center
Verified postcode
Berlin, Germany

Common questions

What is a probiotic?

A probiotic is a type of 'good' bacteria or yeast that can help keep your gut healthy. They are often found in fermented foods or as supplements.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the real supplement but contains no active ingredients. It's used to fairly compare the real treatment's effects.

Can I take my regular blood pressure medication during the study?

The study will determine if existing or new blood pressure medication is allowed; this will be discussed with you during screening.

How long will the study last?

The total duration of your participation, including all visits and follow-up, will be explained to you in detail before you decide to join.

Will I know if I'm getting the probiotic or the placebo?

No, this is a 'blinded' study, meaning neither you nor the study team will know which treatment you are receiving until after the study is complete, to keep the results fair.