Probiotics and the Gut Brain Axis- Do Probiotics Interact With the Vagal Nerve? (ProBIO-HRV)

March 13, 2024 updated by: Medical University of Graz

Pilot-study: Probiotics and the Gut Brain Axis- Do Probiotics Interact With the Vagal Nerve? ProBIO-HRV-study

The purpose of this study is to investigate the effects of a multispecies probiotic on the function of the vagal nerve in patients with major depression and healthy participants in a single-center, randomized, placebo-controlled trial.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After being informed about the study and potential risks, all participants giving written informed consent will be screened for eligibility for study entry and will be randomized in a double-blind manner to receive either a multistrain probiotic or a placebo for 3 months. At entry, 1 week after inclusion, 4 weeks after inclusion and 3 months (end of study) vagal activity will be measured using a 24hr electrocardiogram.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Austria
    • Styria
      • Graz, Styria, Austria, 8036
        • Medical University of Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • informed consenct
  • confirmed diagnosis of depression according to ICD-10 or DSM-V
  • age between 18 and 65 years

Exclusion Criteria:

  • Suicidality
  • no informed consent or no ability to provide consent
  • cardiovascular disease
  • pregnancy, breastfeeding
  • alcohol or drug dependency
  • other severe psychiatric or organic conditions (epilepsy, brain tumor, recent surgery)
  • malignant diseases
  • dementia (MMST<20)
  • severe autoimmune-disorder or immunosuppression (systemic lupus, HIV, multiple sclerosis)
  • antibiotic therapy in the last month
  • misuse of laxative
  • acute infections
  • diarrhoea
  • gastrointestinal surgeries (except appendectomy)
  • no probiotic intake in the last 6 months
  • no regular intake of other supplements, probiotics or antibiotics during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Participants with Major Depression receiving a multi-strain probiotic
Dietary supplement: Multispecies-Probiotic
Participants in intervention group receive 2x3g of a multistrain probiotic containing Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Bifidobacterium lactis W52, Lactobacillus acidophilus W22, Lactobacillus casei W56, Lactobacillus paracasei W20, Lactobacillus plantarum W62, Lactobacillus salivarius W24, Lactococcus lactis W19.
Other Names:
  • Omnibiotic-SR
Placebo Comparator: Participants mit Major Depression receiving a placebo
Dietary supplement: Placebo Supplement
Participants in the placebo group receive 2x3 gram of a placebo supplement not containing probiotic strains.
Other Names:
  • Placebo
Experimental: Healthy volunteers receiving a multi-strain probiotic
Dietary supplement: Multispecies-Probiotic
Participants in intervention group receive 2x3g of a multistrain probiotic containing Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Bifidobacterium lactis W52, Lactobacillus acidophilus W22, Lactobacillus casei W56, Lactobacillus paracasei W20, Lactobacillus plantarum W62, Lactobacillus salivarius W24, Lactococcus lactis W19.
Other Names:
  • Omnibiotic-SR
Placebo Comparator: Healthy volunteers receiving a placebo
Dietary supplement: Placebo Supplement
Participants in the placebo group receive 2x3 gram of a placebo supplement not containing probiotic strains.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of Vagal function
Time Frame: 4 measurements with 24-hr heart rate variability at study entry, one week after, 1 month after and after 3 months
Heart rate variability parameters (logRSA; SDNN)
4 measurements with 24-hr heart rate variability at study entry, one week after, 1 month after and after 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of C-reactive protein (CRP)
Time Frame: 4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)
CRP is measured from serum samples with a Cobas analyzer.
4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)
Change of Interleukine-6 (IL-6)
Time Frame: 4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)
IL-6 is measured from serum samples with a Cobas analyzer.
4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)
Change of Oxytocin
Time Frame: 4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)
Oxytocin will be measured from serum samples using ELISA
4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)
Change of Gut microbiome analysis
Time Frame: 4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)
16S sequencing of gut microbiome samples, gut microbiota composition will be investigated with QIIME2 and characterized in terms of diversity (alpha-diversity, beta diversity) and differential bacterial abundance between time points.
4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)
Change of Body mass index
Time Frame: 4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)
Weight will be measured with a calibrated scale, height will be measured with a non expandable tape. BMI will be calculated using the formula [kg/m2].
4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)
Mini-international neuropsychiatric interview (M.I.N.I.)
Time Frame: at study entry
short structured clinical interview which enables researchers to make diagnoses of psychiatric disorders according to DSM-IV or ICD-10
at study entry
Change in Hamilton Scale for Depression (HAMD)
Time Frame: 4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)
Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression
4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)
Beck Depression Inventory (BDI)
Time Frame: Change in 4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)
21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. The rating is as follows: 0-13: minimal depression 14-19: mild depression 20-28: moderate depression 29-63: severe depression
Change in 4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)
Change in Pittsburgh Sleep Quality Inventory (PSQI)
Time Frame: at study entry, after 7 days, after 4 weeks and after 3 months
The PSQI is used to rate sleep quality. It includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The subscores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality.
at study entry, after 7 days, after 4 weeks and after 3 months
Change in Adult Attachment Scale
Time Frame: at study entry, after 7 days, after 4 weeks and after 3 months

The scale consists of 18 items scored on a 5 point likert-type scale. It measures adult attachment styles named "Secure", "Anxious" and "Avoidant", defined as:

  • Secure = high scores on Close and Depend subscales, low score on Anxiety subscale
  • Anxious = high score on Anxiety subscale, moderate scores on Close and Depend subscales
  • Avoidant = low scores on Close, Depend, and Anxiety subscales
at study entry, after 7 days, after 4 weeks and after 3 months
Change in "Wiener Ernährungsprotokoll"
Time Frame: at study entry, after 7 days, after 4 weeks and after 3 months
24-hr food recall
at study entry, after 7 days, after 4 weeks and after 3 months
Change in International Physical Activity Questionnaire
Time Frame: at study entry, after 7 days, after 4 weeks and after 3 months
The IPAQ is a 27-item self-reported measure of physical activity for use with individual adult patients. There are no validated cut-offs.
at study entry, after 7 days, after 4 weeks and after 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Graz

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Allergosan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 16, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EK1019/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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