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| Name | Class |
|---|---|
| Allergosan | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Major Depression receiving a multi-strain probiotic | Experimental | Participants with Major Depression receiving a multi-strain probiotic |
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| Participants mit Major Depression receiving a placebo | Placebo Comparator | Participants mit Major Depression receiving a placebo |
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| Healthy volunteers receiving a multi-strain probiotic | Experimental | Healthy volunteers receiving a multi-strain probiotic |
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| Healthy volunteers receiving a placebo | Placebo Comparator | Healthy volunteers receiving a placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multispecies-Probiotic | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Vagal function | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of C-reactive protein (CRP) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Graz | Styria | 8036 | Austria |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| Placebo Supplement | Dietary Supplement | Participants in the placebo group receive 2x3 gram of a placebo supplement not containing probiotic strains. |
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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 | 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 | 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 | 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.) | 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) | 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) | 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) | 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 | 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:
| at study entry, after 7 days, after 4 weeks and after 3 months |
| Change in "Wiener Ernährungsprotokoll" | 24-hr food recall | 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. | at study entry, after 7 days, after 4 weeks and after 3 months |
| D001519 |
| Behavior |