Probiotics and the Gut Brain Axis- Do Probiotics Interact With the Vagal Nerve?
- Conditions
- Depressive Disorder, Major
- Interventions
- Dietary Supplement: Multispecies-ProbioticDietary Supplement: Placebo Supplement
- Registration Number
- NCT04772664
- Lead Sponsor
- Medical University of Graz
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
- informed consenct
- confirmed diagnosis of depression according to ICD-10 or DSM-V
- age between 18 and 65 years
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Participants with Major Depression receiving a multi-strain probiotic Multispecies-Probiotic Participants with Major Depression receiving a multi-strain probiotic Healthy volunteers receiving a placebo Placebo Supplement Healthy volunteers receiving a placebo Healthy volunteers receiving a multi-strain probiotic Multispecies-Probiotic Healthy volunteers receiving a multi-strain probiotic Participants mit Major Depression receiving a placebo Placebo Supplement Participants mit Major Depression receiving a placebo
- Primary Outcome Measures
Name Time Method Change of Vagal function 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)
- Secondary Outcome Measures
Name Time Method Change in Hamilton Scale for Depression (HAMD) 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
Change in Pittsburgh Sleep Quality Inventory (PSQI) 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.
Change of Interleukine-6 (IL-6) 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.
Change of Gut microbiome analysis 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.
Mini-international neuropsychiatric interview (M.I.N.I.) at study entry short structured clinical interview which enables researchers to make diagnoses of psychiatric disorders according to DSM-IV or ICD-10
Change in Adult Attachment Scale 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 subscalesChange in "Wiener Ernährungsprotokoll" at study entry, after 7 days, after 4 weeks and after 3 months 24-hr food recall
Change of Oxytocin 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
Change of C-reactive protein (CRP) 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.
Change of Body mass index 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 \[kg/m2\].
Change in International Physical Activity Questionnaire 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.
Beck Depression Inventory (BDI) 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
Trial Locations
- Locations (1)
Medical University of Graz
🇦🇹Graz, Styria, Austria