Depressive Disorder, MajorProBIO-HRVNCT04772664
Probiotics and the Gut Brain Axis- Do Probiotics Interact With the Vagal Nerve?
A study testing Multispecies-Probiotic in people with Depressive Disorder, Major, run by Medical University of Graz at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Multispecies-Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteAustria
- Study dates
- 16 Aug 2021to 30 Oct 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- informed consenct
- confirmed diagnosis of depression according to ICD-10 or DSM-V
- age between 18 and 65 years
Who cannot join
- 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)
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Depressive Disorder, Major
- Being tested
- Multispecies-Probiotic, Placebo Supplement
- Keywords
- depression, vagal function, multispecies probiotic, heart rate variability
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multispecies-ProbioticDietary supplement
Also called Omnibiotic-SR
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.
Placebo SupplementDietary supplement
Also called Placebo
Participants in the placebo group receive 2x3 gram of a placebo supplement not containing probiotic strains.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Major Depression receiving a multi-strain probiotic | Experimental | Participants with Major Depression receiving a multi-strain probiotic Receives: Dietary Supplement: Multispecies-Probiotic |
| Participants mit Major Depression receiving a placebo | Placebo comparator | Participants mit Major Depression receiving a placebo Receives: Dietary Supplement: Placebo Supplement |
| Healthy volunteers receiving a multi-strain probiotic | Experimental | Healthy volunteers receiving a multi-strain probiotic Receives: Dietary Supplement: Multispecies-Probiotic |
| Healthy volunteers receiving a placebo | Placebo comparator | Healthy volunteers receiving a placebo Receives: Dietary Supplement: Placebo Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Vagal function
Heart rate variability parameters (logRSA; SDNN)
Measured: 4 measurements with 24-hr heart rate variability at study entry, one week after, 1 month after and after 3 months
Secondary outcomes (12)
Change of C-reactive protein (CRP)
CRP is measured from serum samples with a Cobas analyzer.
Measured: 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)
IL-6 is measured from serum samples with a Cobas analyzer.
Measured: 4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)
Change of Oxytocin
Oxytocin will be measured from serum samples using ELISA
Measured: 4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)
Change of Gut microbiome analysis
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.
Measured: 4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)
Change of Body mass index
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].
Measured: 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.)
short structured clinical interview which enables researchers to make diagnoses of psychiatric disorders according to DSM-IV or ICD-10
Measured: at study entry
Change in Hamilton Scale for Depression (HAMD)
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
Measured: 4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)
Beck Depression Inventory (BDI)
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
Measured: 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)
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.
Measured: at study entry, after 7 days, after 4 weeks and after 3 months
Change in Adult Attachment Scale
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
Measured: at study entry, after 7 days, after 4 weeks and after 3 months
Change in "Wiener Ernährungsprotokoll"
24-hr food recall
Measured: at study entry, after 7 days, after 4 weeks and after 3 months
Change in International Physical Activity Questionnaire
The IPAQ is a 27-item self-reported measure of physical activity for use with individual adult patients. There are no validated cut-offs.
Measured: at study entry, after 7 days, after 4 weeks and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start16 Aug 2021
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Institut AllergoSan Pharma GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772664
- Sponsor's protocol ID
- EK1019/2021
- Acronym
- ProBIO-HRV
- Status last verified
- Mar 2024
- First submitted
- 23 Feb 2021
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot-study: Probiotics and the Gut Brain Axis- Do Probiotics Interact With the Vagal Nerve? ProBIO-HRV-study
- ClinicalTrials.gov ID
- NCT04772664
- Acronym / sponsor ID
- ProBIO-HRV / EK1019/2021
- Conditions
- Depressive Disorder, Major
- Keywords
- depression, vagal function, multispecies probiotic, heart rate variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Institut AllergoSan Pharma GmbH
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 26 Feb 2021 (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.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Participants with Major Depression receiving a multi-strain probiotic | Experimental | Dietary Supplement: Multispecies-ProbioticParticipants with Major Depression receiving a multi-strain probiotic |
| Participants mit Major Depression receiving a placebo | Placebo comparator | Dietary Supplement: Placebo SupplementParticipants mit Major Depression receiving a placebo |
| Healthy volunteers receiving a multi-strain probiotic | Experimental | Dietary Supplement: Multispecies-ProbioticHealthy volunteers receiving a multi-strain probiotic |
| Healthy volunteers receiving a placebo | Placebo comparator | Dietary Supplement: Placebo SupplementHealthy volunteers receiving a placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- informed consenct
- confirmed diagnosis of depression according to ICD-10 or DSM-V
- age between 18 and 65 years
Key exclusion criteria (16 listed)
- Suicidality
- no informed consent or no ability to provide consent
- cardiovascular disease
- pregnancy, breastfeeding
- alcohol or drug dependency
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 |
|---|---|---|
| Multispecies-ProbioticAlso: Omnibiotic-SRParticipants 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. | Dietary supplement | Healthy volunteers receiving a multi-strain probiotic, Participants with Major Depression receiving a multi-strain probiotic |
| Placebo SupplementAlso: PlaceboParticipants in the placebo group receive 2x3 gram of a placebo supplement not containing probiotic strains. | Dietary supplement | Healthy volunteers receiving a placebo, Participants mit Major Depression receiving a placebo |
Primary outcome
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)
12 secondary outcomes
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)
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)
Change of Oxytocin
Time frame: 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)
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)
Mini-international neuropsychiatric interview (M.I.N.I.)
Time frame: 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)
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)
Change in Pittsburgh Sleep Quality Inventory (PSQI)
Time frame: 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
Change in "Wiener Ernährungsprotokoll"
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multispecies-Probiotic in people with Depressive Disorder, Major, run by Medical University of Graz at 1 site in Austria.
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 16 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: finished, as of the sponsor's last update on 15 Mar 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 Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2024; AzTrials last refreshed its copy on 3 Nov 2026.