HypertensionHYPRONCT03906578
Effects of a Probiotic in Hypertension
A study testing Vivomixx® in people with Hypertension, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Vivomixx®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- 2 Sep 2019to 1 Sep 2025
- Phase
- Interventional
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Secondary causes of hypertension
- Known target organ damage
- 10 years cardiovascular risk score of >20%
- Diabetes
- Established cardiovascular or renal disease
- Other serious diseases
Show all 12Show fewer
- Recent use of antibiotics
- Specialized diets, e.g. use of probiotics
- Comments:
- Two inclusion criteria were changed in June 2021 to improve recruitment
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Probiotic on Blood Pressure in Low-to-moderate Risk Grade 1 Hypertension - a Randomized Study
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.
- Conditions
- Hypertension
- Being tested
- Vivomixx®, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivomixx®Dietary supplement
Microbiotic food supplement with L. paracasei, L. plantarum, L. acidophilus, L. delbrueckii, B. longum, B. infantis, B. breve, S. thermophilus
PlaceboOther
Placebo with similar appearance to probiotic
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Two sachets Vivomixx® containing 8 strains of life bacteria (9 x 10^11 CFU) in the evening for 8 weeks Receives: Dietary Supplement: Vivomixx® |
| Placebo | Placebo comparator | Two sachets placebo in the evening for 8 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nocturnal systolic blood pressure
Measured by 24h ABPM (mmHg)
Measured: After 8 weeks compared to placebo and adjusted to baseline
Secondary outcomes (17)
Nocturnal diastolic blood pressure
Measured by 24h ABPM (mmHg)
Measured: After 8 weeks compared to placebo and adjusted to baseline
24h systolic blood pressure
Measured by 24h ABPM (mmHg)
Measured: After 8 weeks compared to placebo and adjusted to baseline
24h diastolic blood pressure
Measured by 24h ABPM (mmHg)
Measured: After 8 weeks compared to placebo and adjusted to baseline
Office systolic blood pressure
Mean of five consecutive blood pressure measurements (mmHg)
Measured: After 8 weeks compared to placebo and adjusted to baseline
Office diastolic blood pressure
Mean of five consecutive blood pressure measurements (mmHg)
Measured: After 8 weeks compared to placebo and adjusted to baseline
Reduction of antihypertensive medication
Number and dosage of prescribed medication
Measured: After 8 weeks compared to placebo and adjusted to baseline
Glucose variability after standardized breakfasts
Measured by continuous glucose monitoring
Measured: After 8 weeks compared to placebo and adjusted to baseline
Gut microbiome
Change of fecal microbiome composition
Measured: After 8 weeks compared to placebo and adjusted to baseline
Metabolomics stool and serum
Change of fecal and serum metabolome
Measured: After 8 weeks compared to placebo and adjusted to baseline
Change in immune cell phenotypes
Peripheral blood effector T cell frequencies (%)
Measured: After 8 weeks compared to placebo and adjusted to baseline
PROMIS-29 domain pain interference
Range 0-10 with 0 indicating no pain
Measured: After 8 weeks compared to placebo and adjusted to baseline
PROMIS-29 domain depression
Lower (better) T-score (mean 50, SD 10)
Measured: After 8 weeks compared to placebo and adjusted to baseline
PROMIS-29 domain anxiety
Lower (better) T-score (mean 50, SD 10)
Measured: After 8 weeks compared to placebo and adjusted to baseline
PROMIS-29 domain physical function
Higher (better) T-score (mean 50, SD 10)
Measured: After 8 weeks compared to placebo and adjusted to baseline
PROMIS-29 domain fatigue
Lower (better) T-score (mean 50, SD 10)
Measured: After 8 weeks compared to placebo and adjusted to baseline
PROMIS-29 domain sleep disturbance
Lower (better) T-score (mean 50, SD 10)
Measured: After 8 weeks compared to placebo and adjusted to baseline
PROMIS-29 domain ability to participate in social roles and activities
Higher (better) T-score (mean 50, SD 10)
Measured: After 8 weeks compared to placebo and adjusted to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start2 Sep 2019
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Kraeker, Charite University, Berlin, Germany
- Investigators
- Anja Mähler, PhD, Principal investigator, Charite University, Berlin, GermanyDominik N. Müller, PhD, Principal investigator, Max Delbruck Center (MDC)Ralf Dechend, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906578
- Sponsor's protocol ID
- HYPRO
- Acronym
- HYPRO
- Status last verified
- Jul 2024
- First submitted
- 5 Apr 2019
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.
Publications
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.
PubMed 33375942
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Probiotic on Blood Pressure in Low-to-moderate Risk Grade 1 Hypertension - a Randomized Study
- ClinicalTrials.gov ID
- NCT03906578
- Acronym / sponsor ID
- HYPRO / HYPRO
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: Vivomixx®Two sachets Vivomixx® containing 8 strains of life bacteria (9 x 10^11 CFU) in the evening for 8 weeks |
| Placebo | Placebo comparator | Other: PlaceboTwo sachets placebo in the evening for 8 weeks |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- Secondary causes of hypertension
- Known target organ damage
- 10 years cardiovascular risk score of >20%
- Diabetes
- Established cardiovascular or renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vivomixx®Microbiotic food supplement with L. paracasei, L. plantarum, L. acidophilus, L. delbrueckii, B. longum, B. infantis, B. breve, S. thermophilus | Dietary supplement | Probiotic |
| PlaceboPlacebo with similar appearance to probiotic | Other | Placebo |
Primary outcome
Nocturnal systolic blood pressure
Time frame: After 8 weeks compared to placebo and adjusted to baseline
Measured by 24h ABPM (mmHg)
17 secondary outcomes
Nocturnal diastolic blood pressure
Time frame: After 8 weeks compared to placebo and adjusted to baseline
24h systolic blood pressure
Time frame: After 8 weeks compared to placebo and adjusted to baseline
24h diastolic blood pressure
Time frame: After 8 weeks compared to placebo and adjusted to baseline
Office systolic blood pressure
Time frame: After 8 weeks compared to placebo and adjusted to baseline
Office diastolic blood pressure
Time frame: After 8 weeks compared to placebo and adjusted to baseline
Reduction of antihypertensive medication
Time frame: After 8 weeks compared to placebo and adjusted to baseline
Glucose variability after standardized breakfasts
Time frame: After 8 weeks compared to placebo and adjusted to baseline
Gut microbiome
Time frame: After 8 weeks compared to placebo and adjusted to baseline
Metabolomics stool and serum
Time frame: After 8 weeks compared to placebo and adjusted to baseline
Change in immune cell phenotypes
Time frame: After 8 weeks compared to placebo and adjusted to baseline
PROMIS-29 domain pain interference
Time frame: After 8 weeks compared to placebo and adjusted to baseline
PROMIS-29 domain depression
Time frame: After 8 weeks compared to placebo and adjusted to baseline
PROMIS-29 domain anxiety
Time frame: After 8 weeks compared to placebo and adjusted to baseline
PROMIS-29 domain physical function
Time frame: After 8 weeks compared to placebo and adjusted to baseline
PROMIS-29 domain fatigue
Time frame: After 8 weeks compared to placebo and adjusted to baseline
PROMIS-29 domain sleep disturbance
Time frame: After 8 weeks compared to placebo and adjusted to baseline
PROMIS-29 domain ability to participate in social roles and activities
Time frame: After 8 weeks compared to placebo and adjusted to baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Background: PubMed 33375942Mahler 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.
- Protocol publicationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anja Mähler, PhD principal investigator
Charite University, Berlin, Germany
Dominik N. Müller, PhD principal investigator
Max Delbruck Center (MDC)
Ralf Dechend, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vivomixx® in people with Hypertension, run by Charite University, Berlin, Germany at 1 site in Germany.
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 12 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: status not confirmed, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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.
Are results available for this study?
Results are not available in the source record.
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?
Nocturnal systolic blood pressure (time frame: After 8 weeks compared to placebo and adjusted to baseline). 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 NCT03906578, which also lists 1 linked publication.
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 9 Jul 2024.